Past Release Notes

RAMS Customer Release Notes

Release 2.22 March 14th , 2024

Introduction

Thank you for being a valuable customer of RAMS. We are excited to announce our most recent updates and improvements to the platform in our continuous efforts to serve you better. The following list outlines the four main sections of this document. Each section contains important information about this RAMS release. For detailed help instructions, please visit the RAMS Help Center.

What’s New
Updates or Improvements
Bug Fixes
Known Issues

1. What’s New

2. Updates or Improvements

Trainings:

Subscribers of Emergo Pro Plus and Emergo Pro bundles can now purchase the training tool at a discounted rate of $299 (instead of $599).
Trainings purchased will now be displayed in Services of Account Settings.

Regulatory Reports:

Updated regulatory reports of following markets:
- China
- European Union
- Malaysia
- South Korea
- United Kingdom
An option is provided for clients to view a demo report before purchasing a subscription to the Reg Reports via a button named “Sample Report” view.

Registration Tracker:

User are allowed to add IFU version numbers and Label version numbers to an existing or new registration tracker record via Add record manually or Bulk Upload & also through edit record functionality.
A list of default value for the “Alert Date” field when adding a new entry in the registration tracker is incorporated. This value will be pre-filled when creating a new Registration Tracker entry but can be modified at any time by the user.
An option is provided to the Users to modify the number of team members in the sizes of 5 via “Modify Account” under Account settings-->> Services.
Column options is now enabled to be user specific.
Pagination implemented after 50 records and includes left & right facing chevron.

Regulatory Watch:

In Regulatory watch, articles in the “New” tab, Client can flag or archive via the three dots or by clicking on the symbol in the upper right corner directly without clicking the 3 dots.
Pagination implemented after 50 records and includes left & right facing chevron.

Help & Support:

Introduced "Regulatory Support" feature for the users to inquire about regulatory services in "Help & Support" page.

Smart Docs:

Smart Docs information is updated in Virtual Tour and Marketplace.
Display of data is standardized in respective services within Smart Docs.
“Upload” Page:
- Enabled file(s) drag & drop feature.
- A new field “Medical Discipline” has been added.
- Implemented Category and Sub-Categories related to Registration Tracker.
Document expiration date can now be modified even after document is expired.
Smart Docs storage and access to files is allocated accordingly as and when account is converted from Representative to Commercial and vice versa.
Enabled restrictions on accessing files which are used in another module(s).
Introduced search feature to fetch results based on Project/Folder/Document name.

Smart Builder

Text font size has been reduced by 1 point in the output files of all the builders.
While uploading documents from Smart Docs, option is provided to select file(s) from other services such as Agreements, Registration Tracker, and Smart Exchange.
BR Registro V2023:
- From “Technical Documents” Node, moved Clinical Evaluation to “Clinical Evaluation” Node.
- Comparison table to “Technical File Detailed Device Description” Node.
- Updated the labels to match ANVISA requirements.

Smart Exchange

Introduced new market “EU AR and AU”.
Following enhancements were made in various modules:
- In module “QuickReview - EU/UK/CH - Doc Review”, added a new (optional) section “Device Notification Questionnaire” has been added.
- In module “Article 22 - Europe - AR Doc Review – MDR”, a new section “Device Notification Questionnaire” has been added to the existing sections.
- New status “Cancelled” has been added to the existing list of statuses.

3. Bug Fixes

Fixed incorrect team members count reflecting in Account Settings--> Services.
MX FDA Equivalence, in “Technical Summary” node the following bugs were fixed:
- A new field to enter sterility information will now appear when option “Yes” is selected for question “Are your devices sterile?”.
- Contents of Sterility information field will be printed in the output file.

4. Known Issues

In Smart Docs, the files uploaded via “Smart Docs” option from Smart Builder, Smart Exchange, Agreements and Registration Tracker services, are not visible.

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RAMS Customer Release Notes

Release 2.21 November 23rd , 2023

Introduction

What’s New
Updates or Improvements
Bug Fixes
Known Issues

1. What’s New

Product Listing Manager:
- New market “New Zealand” is introduced in Product Listing Manager.
Trainings:
- A new module “Trainings” is introduced to provide medical and compliance knowledge.
- Purchased training will be accessible to all the team members (of respective account purchased by Account Owner) with a validity of 1 year from the date of purchase.

Smart Builder:

Smart Exchange

2. Updates or Improvements

Regulatory Reports:

Following Country Report(s) are updated:
- Colombia
- India
- Malaysia
- Singapore
- Thailand
- Vietnam

Product Listing Manager:

“Classification” will be mandatory for the markets.
Added new classifications for “United Kingdom” market.
For “United Kingdom”, “European Union” and “Switzerland” markets, “MDR – Class I, reusable” is updated to “MDR – Class I, reusable surgical instrument.

Representation Resources:

Guides and Templates:
- A new tab “Vigilance” is introduced.
- New country “United States” is added to the existing markets.

Registration Tracker:

For new commercial users, “Purchase” option has been enabled.
“Product Family” and “Product Type” fields are renamed as “Device Family” and “Device Type” respectively to keep it consistent.
When Record Type “Other” is selected, Users must enter the details in a new (text) field.

Product Classification:

Users can delete completed classifications for any product/ device classification except for EU MDR/IVDR classification for which rational report and/or expert review has been purchased.
Details of User who has created the classification can be viewed going forward.

Regulatory Watch:

For new commercial users, “Purchase” option has been enabled.
New options are introduced to filter past 30 days, past 6 months and past year’s information.

Smart Docs:

Additional storage of Smart Docs can be purchased through Registration Tracker.
Document storage and retrieval is enabled between Smart Docs and Agreements, Smart Builder and Smart Exchange modules.
The link to password set up during sign up is extended to 24 hours and 6 hours for forgot password.

Smart Builder

BR Registro V2023:
- BR Registro builder has been restructured for compliance to RDC 751/2022.
MDR TDF:
- In Node 3, the following question is added: “Are there any variants for the device?”
- In Node 9, the following question is added: “Are there any Stability, Shelf-Life Validation, and/or Device Package Testing to report for the device?”
MDR CER:
- In Appendix B, a new widget “Excluded Articles” has been introduced to access excluded articles in “Safety and Performance” and/or “State of the Art”.
- In Literature Review widget, in citations upload, two additional headers “First Author” and “Publication Date” have been introduced.

Smart Exchange

New UKRP project has been added to United Kingdom Clients.
Search criteria would be applicable to all the toggles.

3. Bug Fixes

4. Known Issues

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RAMS Customer Release Notes

Release 2.20 August 17th, 2023

Introduction

What’s New
Updates or Improvements
Bug Fixes
Known Issues

1. What’s New

Regulatory Reports:
- Following new market have been added:
  - Peru
Regulatory Process Chart:
- Following new market has been added:
  - Bhutan

Smart Builder:

Smart Exchange

Following new templates has been added:
- UKRP Registration - Europe - AR Doc Review - Additional Product – IVDD
- MDR Transition Review - EU/UK/CH/AUS - MDR Transition Extension

2. Updates or Improvements

Regulatory Reports:

Following Country Report(s) are updated:
- Australia
- Hong Kong
- Singapore
- Switzerland
- United States of America (including renaming of Classifications)

Regulatory Essential Report tab and Download Regulatory Report section are removed from Product Classification Section.
For the agreement section, an additional document type is available for all countries: Addendum – Name Change.
The Registrations Expiring Soon email that is sent out, will include the following fields along with "Account ID" field:
- Account Name
- RAMS ID
In registration tracker, Alert Time frame: if the value is blank or "0", then an email notification will be sent on the last day of expiration(date).
In Agreement section, an additional document type field is added which is available for all countries – “Addendum – Name Change”.

Smart Docs:

Introduced virtual tour for Smart Docs.
Complimentary storage of 1 GB has been allocated to each account.

Smart Builder

Two-way sync:
- Two-way sync feature is introduced for the following builder:
  - UKCA TF and EU MDD CER
BR Registro V2023:
- Modifications were made to modification history module which will display the original text, updated text and a text widget to enter justification for the change.
MDR CEP:
- Text changes are applied to various sections of Node 3, 6, 7 and 8.
MDR CER:
- In cloned projects, the hyperlinks in Appendices A and B are disabled.
- Class III enhancements:
  - Allow numbered sub sections to address complicated sections.
  - Manual linking of references.
  - Ability to attach clinical related documents to Appendix G summary of Clinical Data Generated and Held by the Manufacturer.
  - Introduced an option (checkbox) to add sub section to paragraphs.
- In Appendix G, included text box (clinical-related documents) with an option to upload files.
- In Appendix A, the following changes are implemented:
- Following tables will be prepopulated:
  - Safety and Performance (S&P)
  - State of the Art (SOA)
- Following questions have been removed:
- “Literature Search and Literature Review Protocol Revision Status”
- “Literature Search and Literature Review Protocol Approvals”
- Automated Appendices C and D scores
  - Tables of following sections in Appendix C is automated to be used in other Nodes.
    - Criteria for Suitability
    - Criteria for Data Contribution
    - Oxford Centre for Evidence-Based Medicine, Levels of Evidence (2011)
    - Disposition and Weighing for Safety and Performance
    - Criteria for State of the Art
    - Disposition for State of the Art
  - For each article used, new module introduced to add score.
  - For each citation evaluated, module will indicate article contributing to S&P and SOA.
  - New logic has been introduced for the question “Do you want to use the Smart Builder Clinical Data Appraisal Protocol template?”
- While inserting references in citations, “Author’s Last Name” and “Year of Publication” has been included.
- In Appendix G, the section “Clinical-related documents” has been converted to a question.
- Textual changes are applied to various sections of Node 4, 5 and 6.
- In Node 4, additional question (with response logic) has been introduced “Does the device have any intended medical purpose?”

510(k) V2021:
- In Node 22 (Attachment), provided option to select all attachment without having to manually select each attachment.
Table orientation (Portrait/Landscape) has been introduced across all Builders/Templates.
Text widgets have been refined across all the builders/templates.
Footnotes has been introduced in the output files across all the builders/templates.

Smart Exchange

For all the active AR address change projects, the expiration date has been changed to January 31st, 2024.
UKRP:
- For UK market Clients, the content in the email notification of project completion has been modified.
Daily consolidated email will be sent to the Clients with the list of projects that have status changed.
Daily consolidated email will be sent to the Clients with the list of projects created.

3. Bug Fixes

4. Known Issues

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RAMS Customer Release Notes

Release 2.19 May 4th, 2023

Introduction

What’s New
Updates or Improvements
Bug Fixes
Known Issues

1. What’s New

User consent notifications in compliance with local regulations.
New module “Smart Docs” has been introduced:
- Smart Docs (SD) is a Regulatory Document Management System within the RAMS platform. SD provides the ability to ORGANIZE all Regulatory documentation in a single repository, LINK to projects/services in RAMS and enables COLLABORATIVE regulatory documents collection required for driving a regulatory process.
Global Search:
- Global search is a keyword(s) based search feature to fetch information from across RAMS application.
Regulatory Intelligence:
- New country “Mongolia” and its respective process charts has been added.
Regulatory Reports:
- New report for India has been added:
  - MD Class A non-sterile, non-measuring

Smart Builder:

BR Registro v2023:
- New BR Registro builder (“BR Registro v2023”) has been implemented as per ANVISA RDC 2022/751.
- This would be the standard builder to be used going forward.
- Existing BR Registro Material and Equipment builders will no longer be available (for new projects) after the release.
- Tracking of changes will be available in new node “Modification History”.

Smart Exchange

2. Updates or Improvements

Regulatory Reports:

Following Country Report(s) are updated:
- Brazil
- Canada
- China
  - MD Class II-III
- Colombia
- India
- Israel
- Japan
- New Zealand
- Saudi Arabia
- South Korea
- Taiwan
- Thailand
- United Kingdom

Representation Resources:

Following countries are removed from Representation resources are removed as Emergo does not offer representation in these countries:
- Bahamas
- Barbados
- Belize
Agreements:
- Updated Countries list in agreements to include only the countries in which the manufacturer has engaged Emergo as its representative.
- Introduced option to add agreements of country that is not mentioned in the countries list.
- Introduced capturing of “Document Type” based on respective country.
Guides and Templates:
- Access to Guides and Templates will based on countries represented.

Accounts Settings (Preferences):

In Registration Tracker, added another column “Recommended by Emergo” is added to display the number of months recommended to be reminded of the renewal.
Renewal timeframe has been set to specific months for respective countries for Rep accounts.

Registration Tracker:

In Registration Tracker, any entry added by Emergo will no longer be editable.

Tools:

New FDA data is updated for “510(k) Review Time Calculator” and “FDA Product Classification Lookup”.
In password setup, “%” and “?” special characters will be allowed going forward.
Design changes have been made in RAMS pages.

Smart Builder

User Manual:
- Existing user manual for the following builders has been replaced with updated manual and only English version will be available:
  - o 510(k) V2021
- User manual in all other languages except English has been removed for MDR TDR builder.
Two-way sync:
- Two-way sync feature is introduced for the following builders:
  - UKCA CER and EU MDR CER
  - UKCA CER and EU MDR CEP
  - UKCA CER and EU MDR TF
  - UKCA TF and EU MDR CER
  - UKCA TF and EU MDR CEP
  - UKCA CER and UKCA TF
BR Registro (both Material and Equipment):
- Table of contents along with appendices and page numbering has been implemented.
MDR CEP:
- Enhanced CEP builder with textual, question addition/removal, and section sequencing changes.
- In Node 7 (State of the Art), all the widgets after the question “Describe the medical field(s) and condition(s) the device is indicated for” have been removed.
- The last section of the export would now be section 5.2. All the other sections have been removed.
- In Node 6 (Scope of Clinical Evaluation), the following first paragraph of section 4.4 has been removed. “The $variable is a/are Class IIb implantable/non-implantable…the device is intended to directly/indirectly/not contact the human body.”
MDR CER:
- For any new project going forward, in section 3.5 of Node 4, the following questions will be removed:
  - Device Degree of Novelty, based on the Degrees of Novelty Card for a Medical Device (reference ANSM Degrees of Novelty Card for a Medical Device).
  - Device Type of Novelty, based on the Degrees of Novelty Card for a Medical Device.
  - Device Type of Technological Innovation, based on the Degrees of Novelty Card for a Medical Device.
  - Device Type of Clinical Innovation, based on the Degrees of Novelty Card for a Medical Device.
  - Describe the device technology/type of product for the Degree of Novelty rationale.
- Enhanced CER builder with textual, question addition/removal, and section sequencing changes.
510(k) V2021:
- Indications for Use (IFU):
  - Would populate in Section 4 of Node 6 (Indications for Use Statement).
  - Would not be in Device Description section under Header 1 of Node 12.
MX US FDA, Health Canada, Japan MLHW:
- Output files in all the allowed formats would now be in “Open Sans” format for all Mexico builders.
Formatting:
- Optimized display of tables created in text widgets.

Smart Exchange

In AR Address change template, sample download of IFU is redirected to new document in Representative resources (European Union à No IFU_AR Address Change.docx).
- New module(s) has been added to the AR Address change template.
In dashboard, both the “Due Date” and “Project Status” widgets will be collapsed by default and can be expanded on demand (“Load graph” and “Load due date”) respectively.
Tool tips for all toggles have been added.
In each project page, respective consultant’s details will also be displayed.

3. Bug Fixes

Corrected EU MDR product classification tool.

4. Known Issues

In Registration Tracker, for alert timeframe with ”0” months remaining, the status will continue to be displayed as “Expiring soon”.

RAMS Customer Release Notes

Release 2.18 January 23rd, 2023

Introduction

What’s New
Updates or Improvements
Bug Fixes
Known Issues

1. What’s New

Regulatory Essentials:
- Following Country Reports are added:
  - China
  - Costa Rica
  - South Korea
  - Thailand
Accounts Settings (Services):
- For both Commercial and Representation users, for team member(s) upgrade and renewal, the option has changed from +1 to +5 series.
User consent for sending marketing emails will be captured for both new and existing User(s) based on the associated/selected country.
In app survey/feedback feature has been introduced in RAMS.
American Express credit card will be allowed during premium service purchase.
Smart Exchange
- Following three new Templates are implemented:
  - Module 55 (Procedure Pack (Art. 12 MDD or Art. 22 MDR) – EU/UK/CH
  - Module 56 (QuickReview – EU/UK/CH – Doc Review)
  - Module 57 (AR Address Update – EU - EUAR)
    - AS per Emergo’s change in documentation which affects around 1500 clients will be able to submit a suite of documents for review.

2. Updates or Improvements

Regulatory Essentials:
- Following Country Report(s) are updated:
  - Australia
- All classes of devices option in the drop-down list is replaced with “All Classifications” across all countries.
Representation Resources:
- Product Tracker:
  - Date time stamp will be captured and displayed for all statuses.
  - In the "Product Removal Request" email sent to the Client, the link will be redirecting to the respective Market/Country tab.
  - Editing the contact(s) or device name will be applicable to specific country/market.
  - Clients will be able to change the contacts at any time, even if the status is submitted or later up to “Registered” or “Registered and Represented”. Once changed, any future automatic email communication would go to the updated contact list.
  - Product tracker summary email notifications will be sent to selected contacts of respective markets.
Registration Tracker:
- In both Manual and Upload, the following field lengths are changed as below:
  - Device Part Number - 750 characters
  - Product Family - 500 characters
  - Comments - 500 characters
- In records, a new column “Created By” will be displayed. Clients will view the name of their team member who created the record and Emergo logo when an entry is added manually or via sync feature.
- In Registration Tracker, file size to upload has been increased to 30 MB.
Password reveal feature is included in Sing up/Login/Forgot Password/Change Password screens.
In Regulatory Process chart, “Regulatory Approval Process for Medical Devices & IVDs” tab will remain for the following markets. However, the "View Time, Cost and Complexity of Regulatory Approval" has been removed since Emergo does not offer registration or representation services in these markets:
- Bahrain
- Ecuador
- Kazakhstan
Tools:
- New FDA data is updated for “510(k) Review Time Calculator” and “FDA Product Classification Lookup”.
Smart Builder
- User Manual:
  - Existing user manual for the following builders has been replaced with updated manual and only English version will be available:
    - EU MDD TF
    - MDD CER
    - MDR TF
    - MDR CEP
    - MDR CER
  - BR Registro (both Material and Equipment):
    - Technical files will be split based on Technical File Appendices and not based on 20 MB file size. After split, files with more than 20 MB size will be split into smaller size.
      - Note: Technical File will remain as a single file.
      - Page numbering will be added to appendices as well.
    - Node 7 (Technical File Appendices):
      - Introduced an ability to add/remove new section(s) with option to upload file(s).
      - All attached files would be included as separate files (less than 20 MB) in the export.
      - Appendices will be able to re-order as per user’s preference.
      - Users will be able to add in a section for a customized Appendix and is include in the Table of Contents.
      - Introduced batch file upload function, instead of having to use the “+Add” for each document
    - MDR CER:
      - Textual and alignment changes have been made to MDR CER builder.
    - UK MDR CER:
      - Two-way sync has been enabled between UK CA CER and EU MDR CER builders.
      - Two-way sync has been enabled between UK CA CER and UK CA TF builders.
      - Cover page would use Manufacturer logo instead of letter head. Acceptable image formats would be PNG, JPEG, BMP and GIF.
    - UK MDR TF:
      - Two-way sync has been enabled between UK CA TF and EU MDD TF builders.
      - Cover page would use Manufacturer logo instead of letter head. Acceptable image formats would be PNG, JPEG, BMP and GIF.
    - MX US FDA:
      - Enhancements are made to the builder to make it more seamless.
    - MX Health Canada:
      - Enhancements to the builder has been made to make it more seamless.
    - IVDR PER:
      - Logic change based on if IVD is software or standalone.
    - Formatting:
      - Table boarders/grid lines are made consistent across all the builders.
      - Cells in the table would be left justified.
      - Table formatting in the input sections will be same as in the output file(s).
Smart Exchange
- Added FAQs document so that Users can refer to the frequently asked questions.
- Dashboard has been optimized to increase speed loading by display 10 records at a time.
- When a user searches any keyword in the dashboard and navigates to a project, upon hitting back button, the same filtered results will be displayed.

3. Bug Fixes

Current utilization of team members has been modified to consider the date of addition when the member was added.

4. Known Issues

Registration Tracker device chart display in smaller screens have been fixed by allowing smaller screen (14 inches).

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RAMS Customer Release Notes

October 13th, 2022

Introduction

Thank you for being a valuable customer of the RAMS application. We are excited to announce our most recent updates and improvements to the platform in our continuous efforts to serve you better. The following list outlines important information about this release. For detailed help instructions, please visit the RAMS Help Center.

What’s New
Updates or Improvements
Bug Fixes
Known Issues

1. What’s New

Smart Builder:

UK MDR 2002 CER:
- New builder UK MDR CER has been implemented in Smart Builder.
UK MDR 2002 TDF:
- New builder UK MDR TDF has been implemented in Smart Builder.
Declaration of conformity:
- Declaration of Conformity would be automatically generated. Additional questions have been added/modified in the following builders:
  - MDD TDF (Node 3)
  - MDR TDF (Node 3)
  - IVDR TDF (Node 3)

Smart Exchange:

A new toggle "Archive" is introduced where the completed, deleted, removed, and expired projects will be displayed and not in the dashboard.
New templates have been added in Smart Exchange.

2. Updates or Improvements

Regulatory Essentials:

Following Countries/ Regions reports have been updated:
- European Union
- Israel
- Brazil
- Taiwan
- Hong Kong
- Colombia

Representation Resources:

Product Tracker:
- Following features has been introduced:
  - Search functionality.
  - Datetime stamp will be captured when status is changed to “Represented” and “Registered and Represented”.
  - New statuses are introduced “Removed”, “Under Review” and “Removal Requested”.
  - Emergo Project Manager will be able to initiate device removal whereas the Customers can either Approve or Decline the removal.
  - Device family will be allowed for multiple markets.
  - During Product creation, limitation of just two contacts has been removed. “Directives” column for Australia and Switzerland markets has been removed from dashboard
Guides and Templates:
- Canada has been removed from Country drop down.
- “Marketing & Sales” have been removed for all Countries.

Regulatory Intelligence:

New process charts for Switzerland have been added.

Designs of Sign up and Login pages have been revamped.

During Sign up, if the country is selected as U.S, “State” and “Zip Code” fields will be mandatory. However, for the rest of the countries, “State” and “Zip Code” fields will remain as optional.

Regulatory Watch:

In Account settings (Regulatory Watch), a search feature has been added to search a country (with predictive text).
Date of publication along with effective date will be displayed for each regulatory watch update.

Registration Tracker:

In Account settings the default “Product Registration” default timeframes are changed for Saudi Arabia and Malaysia as follows:
- Saudi Arabia:
  - For existing clients, if default timeframe (6 months) has not been changed, then the time timeframe will be changed to 8 months.
  - For new clients, default timeframe will be 8 months.
- Malaysia:
  - For existing clients, if the default timeframe (12 months) has not been changed, then the time frame will be changed to 16 months.
  - For new clients, default timeframe will be 16 months.

Government Fee Finder:

Updated the fees for Israel.
Removal of Application Fees for Australia Medical Devices.

Product Classification:

Complimentary access to Product Classification will be limited to one classification and will be complimentary with purchase of any premium service.

Smart Builder

510(k):
- In the coversheet node, when the value of "Type of Predicate" is edited as primary, in the Substantial Equivalence table, it would reflect as Primary predicate accordingly.
- Include comments in export feature has been implemented.
- The input/output logic has been modified for the question “FDA document numbers of all prior related submissions”.
- In Statement or Summary node, the Substantial Equivalence table has been removed and instead only the Substantial Equivalence table from Node 12 would be rendered throughout the builder.
MDR CER:
- Instructions for use question (in section 2.7) will not be displayed for Class IIb or Class III or AIMD devices as there is no possibility of not providing an IFU.
MX US FDA:
- Enhancements to the builder has been made to make it more seamless.
MX Health Canada:
- Enhancements to the builder has been made to make it more seamless.
Device labeling:
- In specific nodes of the following builders, the device labeling has been modified:
  - MDD TF
  - MDR TDF
  - IVDR TDF
User Manual:
- Existing user manual of the following builders has been replaced with updated manual and only English version will be available:
  - 510(k)
  - BR Equipment
  - BR Material
Streamlined table (orientation) formatting, page numbering, fonts etc. for following builders:
- 510(k) V2021
- MDR CEP
- MDR CER

Smart Exchange

"Under Review" projects will be displayed by default at the top of the dashboard list.
In each project page, the Product Name will be displayed.
A new market “Australia” has been added.

3. Bug Fixes

Daily and weekly (Regulatory Watch and Registration Tracker) emails will be sent to Emergo Pro and Emergo Pro Plus users.

4. Known Issues

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RAMS Customer Release Notes

June 30th, 2022

Introduction

Thank you for being a valuable customer of the RAMS application. We are excited to announce our most recent updates and improvements to the platform in our continuous efforts for serving you better. The following list outlines the four main sections of this document. Each section contains important information about the RAMS release. For detailed help instructions, please visit the RAMS Help Center.

What’s New
Updates or Improvements
Bug Fixes
Known Issues

1. What’s New

Representation Resources:

Product Tracker:
- Product tracker has been implemented for the Representation Clients to add their Products/Devices in RAMS and assigned Project Manager can approve/make changes to the products/devices.
Agreements:
- Agreements section is now available for Representation Client. It will provide a one stop source to explore agreements signed by User.
Current Representation Resources page is transferred to new section “Guide and Templates”.

Smart Buidler:

Project export in Word format is implemented in the following builders:
- MX Equivalence Registration: Health Canada
- MX Equivalence Registration: Japan MLHW
- MX Equivalence Registration: US FDA

2. Updates or Improvements

Regulatory Essentials:

The markets list is alphabetized.
Following Countries reports are updated:
- India
- Australia

Representation Resources:

Following additional markets has been added in “Guides and Templates”:
- Brazil
- China
- Colombia
- Costa Rica
- Hong Kong
- India
- Israel
- Malaysia
- Mexico
- New Zealand
- Peru
- Saudi Arabia
- Singapore
- South Korea
- Taiwan
Representation Resources menu design was implemented to include 3 sub sections.
- o Product Tracker
- o Guides and Templates
- o Agreements

Marketplace:

Promotional offer is provided to Clients at $1899 with the same price of Emergo Pro.

Smart Builder:

BR Registro Equipment builder changes are implemented as per ANVISA new regulations.
"Include in Export" feature introduced for comments when exported in Word format for all the builders (except 510(k)).
MDR CER:
- Supplemental search would be displayed as a separate search in “Review Results for Supplemental activities” table.
- Users can add to the “Source” for Supplemental Activities.

Smart Exchange:

The project name and status will be displayed in each project page.
Code is optimized to load the projects quickly.
The feature to display projects “Under Review” first in the dashboard has been rolled back in the recent patch on 6/20/2022. It will be reinstated in 2.17 release.

3. Bug Fixes

4. Known Issues

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RAMS Customer Release Notes

May 26th, 2022

Introduction

What’s New
Updates or Improvements
Bug Fixes
Known Issues

What’s New

➢ Product Classification

- Added product classification for United Kingdom.

➢ Regulatory Reports:

Added Regulatory Reports for the following countries:
- Saudi Arabia
- Taiwan
- Hong Kong
- Canada

➢ Representation Resources:

A new radio button “Marketing & Sales” has been introduced to filter documents related to marketing and sales.

➢ Marketplace:

New RAMS service “Emergo Pro & Emergo Pro Plus” with purchase option has been introduced in Marketplace.
New affiliated service “Human Factors Intelligence” has been introduced.
New design incorporated for Marketplace.

➢ Notification on network interruption

Whenever there is a network interruption, a default network issue page will be displayed in RAMS application if User navigates/reloads the page.

➢ Smart Builder

Project export in Word format is implemented in the following builders:
- BR Registro Material
- IVDR TDF
- IVDR PEP
- IVDR PER
- BR Registro Equipment
- MDD CER
- MDD TF
- Traditional 510(k)
- 510(k) v2021

Updates or Improvements

➢ Product Classification:

Updates and definition of “Serious Disease” has been updated in Australia Product Classification.

➢ Regulatory Essentials:

Updated Regulatory Essentials for the following countries:
- New Zealand
- USA
- Mexico
- Brazil
- India
- E.U (replaced)

➢ Government Fee Finder:

Registration fees for the country Vietnam will display the lowest risk classification first in the incremental order.

Pricing of Premium Services has been updated.
- New pricing structure has been added to all the RAMS premium services.
- User(s) can purchase additional Bundled service at a pro rata basis if already purchased other service(s). New FDA data is now made available under "Tools" menu.
Updated the Renewal email address in RAMS application from emergo_renewals@rams-track.com to EmergoRenewals@ul.com
In RAMS dashboard (upon login), along with the Company Name, RAMS ID will also be displayed (when clicked on “I” icon).
RAMS performance has been improved to be much faster than before.
Revamped designs for following menu(s)/sections:
- Dashboard
- Regulatory Watch
- Registration Tracker landing page
- Notifications
- Tools

➢ Smart Builder

"Include in Export" feature introduced for comments in the following builders. Selected comments can be included in the final exported document.
- BR Registro Equipment
- BR Registro Material
- MX Equivalence Registration Health Canada
- MX Equivalence Registration Japan MLHW
- MX Equivalence Registration US FDA
510(k) v2021 builder:
- Export will be auto split into multiple files if it exceeds 50MB.
- BR Registro Material builder:
  - Updated the logic that if legal manufacturer is based on Brazil, no PDF will be generated in the export.
- 510(k) builder:
  - Node 2 - Added a new question (“Is a medical device user fee cover sheet required?”). If “Yes”, an option to upload attachment will be provided. If “No”, not required to upload attachment.
  - Node 3 – Added “Reference Device” drop down option for Equivalence category. If “Reference Device” is selected, a new column will be added at the end of Substantial Equivalence table (Node 14).
  - Node 14 – Introduced a check box. If checked, the details will not be displayed in the Substantial Equivalence table. If unchecked, then the details will be displayed in the Substantial Equivalence table.
- MDR TDF builder:
  - Node 5 - Added a widget to Add Image/Add Text/Import Table/Add Table for question “Does device contain any raw materials”.
  - Node 8 – Added a widget to Add Image/Add Text/Import Table/Add Table if the response is “No” to question “If full benefit risk analysis will be provided”. In the output, updated the text to indicate the reason for not warranting a full benefit risk analysis.
  - Node 9 – Provided a designated place to record test article extraction conditions. In the output, an additional column will be added with the test articles.
- MDD and MDR CER builders:
  - Appendix A - Added “BfArM Field Corrective Actions (Germany)” in Reportable events database searched section.
  - Provided option to add dates of searches, listing the limits, terms queried, Field corrective actions search results and discussion based on the “BfArM” option selection.
  - Appendix B - For literature search “Embase”, additional text is added in Table B-2 indicating the source & trademark information.
In any builder, disabled selection of any option once section of a node is finalized. Following are the event/actions that will be disabled.
- List of acronyms
- Upload
- Manufacturing information section
- Citation dropdowns
- Substantial equivalence discussion text boxes and labels
- Attachments, Add buttons and radio buttons in 510(k) builder
- Text in textboxes in Mexico and Brazil builders.
In any builder, “Save” button is provided for the user to save the input data. If navigated away from the current page, a pop up will be displayed indicating to proceed with or without saving the data.
In any node where upload option is provided, a note has been mentioned to avoid uploading password protected PDF.

➢ Smart Exchange

Along with Company Name, RAMS ID will also be displayed.
Projects with status “Under Review” will be displayed at the top by default in the projects list (in dashboard).
In the Project Due report, added new fields “Market”, “Primary Reviewer Name”, “Final Reviewer Name” and “Project Manager Name” fields to the existing fields/template based on the logged in user type.

Fixes

Registration Tracker upgrade redirection issue has been resolved.
Registration Tracker reports rendering issue is resolved when user has more than 2500 records.
Display of incorrect Team member count upon deactivation of any user(s) has been fixed.
In SX dashboard, the project status is showing incorrectly in the “Due” section Vs. dashboard. This issue has been resolved.

Known Issues

In Service purchase, existing total limits for team members and records is not showing accurately. This will be address in the next release (2.16).
On successfully renewal of single or multiple services, “Purchase” or “Try for Free” button is currently being displayed in Marketplace offer section which is not supposed to be displayed. This issue will be address in 2.16 release.
As part of export in Word format implementation, few known issues such as image alignment, text formatting (in some instances, page number (in Portuguese and English Word export) etc., have been identified. These known issues will be addressed in subsequent release.

______________________________________________________________________________________

RAMS Customer Release Notes

Introduction

What’s New
Updates/Improvements
Fixes
Known Issues

What’s New

➢ System Maintenance Notification

A new System Maintenance Notification is displayed when a user is logged into the RAMS application, to notify the user about an upcoming system maintenance window.

➢ Smart Builder

Project export in Word format is implemented in the following builders:
- MDR CEP
- MDR CER
- MDR TDF
Supplemental Document is added in each builder in addition to the user manual.

Updates/Improvements

➢ Product Classification Updates

The Product Classification documents for the UK Market have been updated.

➢ Smart Builder

"Include in Export" feature introduced for comments in the following builders. Selected comments can be included in the final exported document.
- MDR CER
- MDD TF
- MDR TDR
- IVDR TDF

Disabled selection of following options once any section has been finalized
- Yes/No Radio buttons
- Image/Text/Table
- Comments

➢ Smart Exchange

In each project page, a note has been added to advise the User on applicable document formats and naming restrictions for files supplied via "Upload" field.

Fixes

The back button displayed in the Virtual Tour window now functions properly.

Known Issues

The Product Classification tool presents an Incorrect flow of sequence when selecting the option "18” and selecting different combinations of "UK MDR 2002 UKCA Classification Rules"/"European Union (MDD)" from the Country drop-down menu and entering the device name.
The Product Classification tool also generates Class IIb instead of Class III, for Question 28 and option 3, when selecting "UK MDR 2002 UKCA Classification Rules"/"European Union (MDD)" from the Country drop-down menu and entering the device name.

___________________________________________________________________________________________

Last updated on January 28th, 2022

RAMS Customer Release Notes

January 28th, 2022

Introduction

Thank you for being a valuable customer of the RAMS application. We are excited to announce our most recent updates and improvements to the platform in our continuous efforts for serving you better. Each section contains important information about the RAMS release. For detailed help instructions, please visit the RAMS Help Center.

What’s New
Updates/Improvements
Fixes

What’s New

➢ Resources section

Vietnam government fees were added to the Government fee tool.

➢ Regulatory Intelligence - FAQ section

The Regulatory Intelligence FAQ section now has a new search feature.

➢ Smart Exchange

Introduced ability to download all documents in a project as one zip file.

➢ Regulatory Essentials Reports

5 new Countries: US, Brazil, India, Singapore, and Malaysia have been added to the Regulatory Essentials Reports.

Updates/Improvements

➢ Login and Signup

The FAQ Link has been added to the Login Screen that navigates to the Knowledge Center Page.

➢ Regulatory Intelligence in the Marketplace

Updates were made to the countries Israel, Saudi Arabia, and Turkey, in the Regulatory Intelligence in the RAMS Marketplace

➢ Regulatory Essentials Reports

The Regulatory Essentials Reports have been updated for Australia, Europe, Israel, and Mexico.

➢ RAMS Dashboard and Marketplace Web page

Updated design of the Dashboard and Marketplace.

➢ Payments Methods

Purchase Order option is now included within the Invoice method.

➢ Date Selection on the Notifications Page

The calendar displayed in the Notifications Page, which allows a user to select the date range, has been upgraded to enhance the user's experience.

➢ Registration Tracker

The Registration Tracker product filter now allows a user to select multiple products and then the user can select a country from the dropdown to export the report.

➢ Design Changes

Overall design changes of various menus, filters, buttons, and pop-ups.

➢ Smart Builder

Optimized code to enhance the speed and performance of all builders.
Update the sync feature to include new sync between the following:
1. From PEP to PER and vice versa.
2. From MDD CER to MDR CER and vice versa.

Introduced Sync between IVDR TDF and IVDR PER builders.
Introduced standard display of due date in “DD MM YY” format for SB nodes.
Added text in Manufacturer Short Name field in all builders to include Manufacturer name if short name is not available.
Implemented CKEditor Upload Adapter to allow users to insert images inline via the editor.
"Include in Export" feature introduced for comments in MDR CER and CEP builders. Selected comments can be included in the final exported document.

➢ Smart Exchange

Optimized code to increase the speed and performance of the platform.
Display dashboard in a table format for easier navigation.
Ability to display a matching document name of an existing file also in a downloaded file, so no renaming necessary.

Fixes

Previously, when a user hovered the mouse pointer over any country which had only 1 record, the pop-up with the registration details did not appear. This has now been fixed.
Both distributor and report viewer users are now able to receive records expiring soon notification emails.
Base price was displayed instead of actual price for Billing Amount for Service, for all users who purchased a service and received the service purchased email notification.
Users were unable to see the selection panel when trying to customize a dashboard after adding Smart Exchange project.
Records expiring soon emails are being triggered to account owner.
Smart Builder:
1. Revision History and List of Acronyms are now part of ZIP export as well.
2. Table break issues in Traditional 510k builder are now resolved.

___________________________________________________________________________________________

Last updated on October 14th, 2021

October 14th, 2021 Release Notes

Introduction

What’s New
Updates/Improvements
Fixes
Known Issues

What’s New

➢ Smart Builder

Loading spinner display while navigating from one page to another indicates of a background activity.
Consultants can now post comments for internal discussion. Client and Consultant comments can be differentiated via blue (external) and green (internal) colours.
Applicable Guidelines & standards added in Node 6 of TDF builder similar in format to CER acronyms.
User will be able to toggle existing comments within the comments that will be added to the exported documents if user clicks on "Include in export" (applicable for IVDR PEP and PER builders).
Pop up message will be displayed on “Generate PDF” on “Exports” tab if export is too big (over 50 MB) for traditional 510(k) builder.
Peer review process is streamlined by allowing PMs to delete the internal comments before final deliverable is published to the client.

➢ Smart Exchange

Consultant role type (Primary/Final reviewer) toggle added in the project dashboard.
Implemented new design for comments section.

➢ Credit card payment available

For RAMS Service Subscription/Upgrade/Renewal, payments can now be made through credit card.

➢ Regulatory Reports

Added new Israel reports to the Regulatory Essentials report purchasing options.

➢ Technical support form

RAMS application now has a Help and Support Option for users to contact RAMS support team.

➢ Deactivate Account

Commercial Account Owners will now be able to de-activate their own accounts by themselves.

➢ Market Insights included in Resources Explorer

In the map and list views, the Market Insights shall be available based on the country selection.

➢ Marketplace-Greenlight Guru eQMS re-direction

On click of the “Request Information” button in the Greenlight Guru webpage, user will be re-directed to Greenlight Guru contact us page.

Updates/Improvements

Smart Builder (SB): The following updates/improvements were made to the SB module:

Updated IFUYN (Instructions for use) logic in MDR TDF and MDD TF/CER builders.
Template level changes made in module sections for MDR TDF, MDR TF, and IVDR TDF builders.
Restructured “Proposed Labelling” node based on new design for 510(k) version 2021.
Added a dialogue box to the export page when E-signature is applied (Traditional and 510(k) v2021).
Implemented comments pop up box in CER (Node 13 – Appendix B – Literature Search and Literature Review section).
“Summary of Statement” node is updated as per modified design for 510(k) version 2021 builder.
“Sterilization and Shelf-Life” node is restructured as per the modified design for 510(k) version 2021 builder.
Updated Appendix B of CER builder with the ability to export articles on “Needs full text” and updated Digital Object Identifier (DOI).

Smart Exchange: PM will receive customized emails based on configured changes on module templates.
Sign Up page: Updated error message on email field to reduce fraudulent account creation by restricting public domain email addresses.
Updated login error message: If any user other than Consultant/PM tries to log in without setting up password, an error message “Account set up incomplete” will be displayed. Password can be set up through the “Forgot your password” link.
Government Fee Finder:
- Application fee for Taiwan is updated.
- Updated information for four markets (United States, Saudi Arabia, Egypt, and Malaysia)
Greenlight Guru eQMS: The content and images of Greenlight Guru Marketplace page is revamped with more insights.
Market Insights: New webinar i.e., Multi-market added which provides an overview of key development from global markets including North America, Europe, and Asia Pacific.
Regulatory Reports: Reports updated for European Union and Australia.
Resources->Tools->FDA Product Classification Lookup is enhanced with more data.
Regulatory Intelligence - New button to add free market: For users who have not availed one free market, a button “Add One Free Market” has been added.
Registration Tracker:
1. For Account Owners, “Registrations expiring soon” notifications (In-App and email) will be sent for Emergo managed records, irrespective of notification preference selection.
2. Presentation of Does Not Expire (DNE) in the Tracker-alert dates text modification: The alert date has been replaced with N/A if registration does not expire.
3. Product name that start/end with a special character is considered as invalid and an error message will be displayed while attempting to bulk upload or manually add them.
Design changes:
1. The drop-down hover over designs has a newer make over across the application. The same design changes apply to the session expiry pop-ups as well.
2. Overall table header tab style across the RAMS application has been made consistent.
Team Member Upgrade – Email blocked users: For the expired accounts, all team members in an account will be notified when blocked.
Regulatory Intelligence: Download updated regulatory intelligence documents covering eight markets through the “Regulatory Intelligence” section of the site.
Process Charts, Document Libraries, and FAQs: Updated for United States, Europe, China, Costa Rica, Egypt, India, Malaysia, South Korea, and Thailand.

Fixes

Reg Reports: Disabled Purchase button on default report.
Registration tracker-Able to save records with validation rules in place for each attribute.
User now receives email/notification for Production Classification sign-up.
Validation message when deleted user re-activation occurs in sign-in page.
Users can now access IVD project in production.
Issue with publication in EU MDR CER - Appx B - Literature Search & Literature Review. The publication is not being removed from Need Full Text Review tab after being dispositioned.
In EU MDR CER builder, for product “Betadine Throat Spray 0.45”, saving post literature review update is faster.
Marketplace-> Product Classification – Previously Purchase link was wrongly pointing to a different page, now shows the correct purchase screen.

Known Issues

Market insights status not showing correct for few webinars and podcasts.

Last updated on August 13, 2021

August 13th, 2021 Release Notes

Introduction

Thank you for being a valuable customer of the RAMS application. We are excited to announce our most recent updates and improvements to the platform. The following list outlines the four main sections of this document. Each section contains important information about the RAMS release. For detailed help instructions, please visit the RAMS Help Center

What’s New
Updates/Improvements
Fixes
Known Issues

What’s New

➢ RAMS Regulatory Review podcast:

The Market Insights section under the Resources now includes podcasts to all RAMS subscribers. Our initial two episodes have been released. Stay tuned for more discussions with our global regulatory experts only available on RAMS.

➢ Service Expiry pop-up banner:

New “dismiss” and “do not show me this reminder again” options are available to remove expiration banner warnings for individual users.

➢ Regulatory Intelligence:

New UK IVD Process Chart

➢ Technical Support Access:

To assist with troubleshooting, subscribers can grant Emergo personnel temporary access to their account using a new checkbox available under Profile settings. Access can be revoked at any time and automatically expires after 72 hours.

➢ Consulting Account type:

Emergo consulting clients will now receive automatic complimentary access to the Regulatory Intelligence premium service via a special RAMS account type. Reach out to your Emergo contact if you have not already taken advantage of this great benefit.

Updates/Improvements

Service Expiry pop-up banner: On Expiring Soon banner, Team Member service text has been updated for clarity.
Registration Tracker: The “Contact Emergo for Renewal Support” link is now available at the top of Registration Tracker records for 22 countries making it even easier to reach out for support with the click of a button.
Registration Tracker: In-Country Representation client registration records have been updated to reflect the Emergo entity representing that product in the related market.
Government Fee Finder: Australia fees have been updated.
Market Insights: Activity tracking capabilities added. Now you can resume a webinar or podcast from where you last left off. Additional sort, search and filter functionality added.
Tool Tips: Tool tips added to “Change Password” feature under Profile settings and the “Restricted Team Members” notice under Team settings.
“Team member upgrade” price list updated: The “Team member upgrade” dropdown selection now accommodates up to 25 members with the appropriate pricing listed. For 25+ pricing, simply reach out using the new contact us link displayed on the upgrade pop-up screen.
Smart Builder:

Improvements made to the Sync functionality – restructured user interface, color coding, and a Help section for EU builders
Updates to Electromagnetic Section (node) in 510(k) v2021 – additional image text tables and upload buttons, new regulatory questions
Updates to Software Section (node) in 510(k) v2021 – restructured design, new regulatory questions to remain aligned with FDA guidelines
Embedded comments can now be displayed in exported files for IVDR PEP and PER builders
Helpful Tip banner added to the 510(k) project pages informing user of file size limitations
Password protection has been removed from exported documents

Smart Exchange: Introduced internal quality review workflow. Introduced ‘Needs Final Review’ status as part of the internal quality review. Now available on the Dashboard “status tracker” widget and project list.
Regulatory Intelligence – Process Charts: Updates for Belarus, Canada, Colombia, Egypt, Indonesia, Pakistan, Peru, South Africa, Taiwan, Australia, New Zealand

Regulatory Intelligence – FAQs: Updates for Belarus, Canada, Colombia, Egypt, Indonesia, Pakistan, Peru, South Africa, Taiwan, Thailand, Australia, Brazil, Hong Kong, New Zealand, Mexico, Singapore
Regulations & Guidances: Updates for Belarus, Canada, Colombia, Egypt, Indonesia, Pakistan, Peru, South Africa, Taiwan, Thailand, Australia, Brazil, Hong Kong, New Zealand, Mexico, Singapore
Regulatory Essentials: Updated all Australian market reports
Product Classification: formatting updates applied to the questionnaires; easy access buttons added to Product Classification results page to allow for quick navigation to Regulatory Essentials and Classification Rationale reports.

Fixes

Registration Tracker: Bulk upload errors related to calendar fields have been resolved
Virtual Tour for Smart Exchange module fixed
Template text updates in MDR CER/CEP builders.
Builder issues related to editor tools have been resolved by initializing the editor when a user clicks into a section as opposed to initializing when page loads.

Known Issues

Responsive issues to be addressed
Registration Tracker: no error message for bulk uploads where cells exceed the 255-character limit. Fix in progress
Registration Tracker: Malaysia default renewal timeframe is set to 18 months prior to expiration. Current regulatory conditions now lean more toward a 12-month renewal timeframe. Update to the default period is in progress.

Last updated on June 11, 2021

June 11th, 2021 Release Notes

Introduction

Thank you for being a valuable customer of RAMS application. We are excited to announce the addition of more functionalities within Resources section – Regulations & Guidances, Regulatory Reports, Regulatory Intelligence, Process Charts, and Product Classification. Additionally, we’ve added a new section called “Marketing Insights” under Resources, which includes webinars, white papers, and other downloadable content. The following list outlines the four main sections of this document. Each section contains important information about the RAMS release. For detailed help instructions, please visit the RAMS Help Center

What’s New
Updates/Improvements
Fixes
Known Issues

What’s New

➢ Market Insights, a new freemium resource:

A free resource that includes webinars, white papers, and other downloadable content to help you navigate global medical device and IVD markets. This content, created by global regulatory affairs experts at Emergo by UL, is developed specifically for regulatory affairs and quality assurance professionals.

➢ IVDR Classification Rationale Report:

Product Classification has expanded to include an EU IVDR Classification Rationale Report, a self-guided report that confirms the applicability of each Rule under the EU In Vitro Diagnostic Devices Regulation 2017/746 (IVDR).

➢ Regulatory Reports:

Regulatory Essentials Reports added 4 new markets, Australia, Colombia, Mexico, and New Zealand. This creates a total of 12 additional MD and IVD reports.

➢ Regulatory Intelligence:

New Process Charts and FAQs added for UK

➢ Resources: Government Fee Finder

United Kingdom fees have been newly added

➢ Regulations & Guidances:

New documentation added for UK

➢ Resources Explorer added to Dashboard (default view)

Discover what RAMS has to offer by using the Resources Explorer directly from your dashboard. The best way to quickly browse all RAMS resources by country.

Updates/Improvements

Government Fee Finder:
- Fees have been updated for Taiwan and Canada.
Virtual Tour new service inclusions updates:
- Market Insights and Regulatory Training and Compliance are newly added to our Virtual Tour.
Regulatory Essentials:
- Now easily view past purchases and download reports at your own convenience.
Resources Explorer:
- Additional information update for map and list views includes:
  1. United Kingdom
    - Regulatory Intelligence
    - Regulations & Guidances
  2. Australia, Colombia, New Zealand, Mexico
    - Regulatory Reports
  3. Saudi Arabia, Peru
    - Representation Resources
Customizable Dashboard:
- Regulatory Watch has been added as an option to the customizable dashboard feature under Account Settings.
Service expiry email has additional information:
- Service expiration email now includes additional details about your expiring Team Member access and how to renew.
Restricting free domain email addresses:
- Sign-up restrictions apply on free domain email addresses.
Free trial activation email:
- Registration Tracker and Regulatory Watch free trial users to receive activation notifications to inform users of free trial activation period.
Regulatory Intelligence – FAQs:
- FAQs screen has been redesigned to better align with the look and feel of RAMS.
Representation Resources
- Documents under Representation Resources are now categorized and can be filtered using the newly established categories.
Product Classification:
- Design changes to Product Classification results page and dashboard. Dashboard updated to display an Upgrade button to users to quickly identify which product classifications have an associated Classification Rationale report available.

Fixes

Responsiveness issues in iPad improved
Product Classification: Bypass unnecessary purchasing screens when activating the free Product Classification (BETA) service.
Registration Tracker: when selecting a Related Record, dropdown selections do not include the record being edited
Registration Tracker: updated document upload error message.

April 09th, 2021 Release Notes

Introduction

Thank you for being a valued customer of RAMS application. We are excited to announce the addition of more functionalities within Smart Builder, Resources section, Regulatory Intelligence and Product Classification. Additionally, we've added a new premium service "ComplianceWire", a learning management system that can help your company comply with 21 CFR Part 11 and EU Annex 11 validation requirements. The following list outlines the four main sections of this document. Each section contains important information about the RAMS release. For detailed help instructions, please visit the RAMS Help Center

What’s New
Updates/Improvements
Fixes
Known Issues

What’s New

➢ Smart Builder:

Two new Smart Builders – IVDR Performance Evaluation Plan and Performance Evaluation Report. Templates are analogous to the existing MDD CEP and CER builders. (IVDR PEP and PER can sync to the IVDR TDF.)
Revamped MDD/MDR CER builder Lit review to address flexibility, user friendly behavior, increased searches, structured response, format/review citations, create revision etc.

➢ Product Classification:

IVDR Classification Kit Flow: Users can now classify IVDR kits with multiple components.
Product Classification free trial expiration date has been moved to 6/30/2021. Users can continue to generate product classifications for all available markets free of charge.

➢ Regulatory Intelligence:

New Process Charts and FAQs added for Ecuador, Chile, El Salvador and Uruguay

➢ Resources: Government Fee Finder

United Kingdom fees have been newly added

➢ ComplianceWire®:

UL’s learning management solution, will now be promoted in the RAMS Marketplace. A dedicated marketing page is available, and subscribers can contact the ComplianceWire team through RAMS.

➢ Renewal Process Incorporated:

Renewals for Registration Tracker, Tracker Upgrades, Regulatory Watch, Regulatory Intelligence, and Team member upgrades can now be processed within RAMS.

Updates/Improvements

Government Fee Finder:
- Global Fee Finder – add last updated date: RAMS now displays the date the fee table was last updated for each specific country.
- Global Fee Finder – country update: Peru and Canada fees have been updated.
Service Name Changes:
- Regulatory Pathway service name has been changed to Regulatory Reports
- Global Fee Finder tool name has been changed to Government Fee Finder
Account Settings-Services:
- Add Usage counter for Pay per use services: Credit-based offerings such as: Essentials Reports, Product Classification, and Classification Rationale reports now display the credits purchased and credit remaining on the Account Services page.
Updates in Sign Up and Login: -
- Updated text on Sign Up screen targeting existing Emergo by UL clients and encouraging them to contact EG to activate their account or contact their own organization to be added to the existing account
- Company name field changed to Legal Company Name. The system will notify a user if an identical company name has already been established an account. It will not prevent users from continuing the sign-up process.
- Users can now request a new verification link to be sent to their email on file.
Product Classification:
- User Interface updates: Minor design changes to Product Classification results page. RAMS logo on Classification Rationale report PDF was updated
Smart Builder:
- Introducing autosaving and warning to users from being timed out from a session
- Added instruction to export of documents in word and zip format
- Users can insert links in dynamic table Widgets
- The list of nodes has been expanded to include section number
Smart Exchange:
- 'Project Background' section added to Projects
- Projects from the Consultant / PM dashboards can be removed completely
- The client has option to choose to receive the project assignment notification email
- PM role enabled with few Consultant roles
- Comments within SX in the comments section can be deleted.
- Provision available to reset the project back to the most recent project status.
- Sorting option available to sort Due Dates by soonest due dates first
- Under Review status alone can be viewed in the due date box
- Email subject line can now be customized
- For Project status “Under Review” of a Consultant “Due Dates” are shown
- Added mechanism so consultant's Due Dates to only show the Due Dates for project status "Under Review".

Fixes

Responsiveness of pie charts enhanced with zoom option for Smart Builder and Smart Exchange
Virtual Tour: Text misaligned in responsive design resolved
Registration Tracker: Pie-charts distortion in responsive designs resolved (iPad)
Page numbering issue in the appendices of BR Registro equipment

Known Issues

Images in ComplianceWire are stretched when zoomed in and some responsive designs
Process Charts and FAQs – responsiveness issues

******************************************************************************

February 05th, 2021 Release Notes

Introduction

Thank you for being a valuable customer of RAMS application. We are excited to announce the addition of more functionalities within Smart Builder, Resources section, Notifications widget, Smart Exchange BETA version and IVD content within Product Classification and Regulatory Pathway. Additionally, we’ve added “Global Fee Finder”, a new tool free to all RAMS subscribers that estimates government fees quickly and easily. The following list outlines the four main sections of this document. Each section contains important information about the RAMS release. For detailed help instructions, please visit the RAMS Help Center.

What’s New

Updates/Improvements

Fixes

Known Issues

What’s New

➢ Smart Builder:

New templates for Mexico Equivalence Registration for US FDA, Health Canada, and Japan MHLW authorization. Templates support English language input to accommodate preparing and submitting your documentation in Spanish.

➢ Resources: Global Fee Finder

“Global Fee Finder” is a new feature under Resources-Tools section to aid in retrieving government fees for various registration and submission types worldwide. This helps identify costs while exploring newer markets or while renewing for existing business.

➢ Regulatory Pathway:

Five (5) new Regulatory Essentials Reports for EU IVDR are now available. Reports are available by classification and can be purchased under the Regulatory Pathway service.

➢ Product Classification (BETA):

Now includes IVDR to streamline EU market access planning. Access to free beta version has been extended to April 9 2021.

➢ Smart Exchange:

Project Manager user role can now view all projects to which they have been given access to within a single consolidated dashboard. This user role can still access and manage projects from each account from their consolidated dashboard, including the ability to impersonate the client, e.g., Account Owner.

Up-dates/Improvements

Notifications widget: The notification widget in the left panel now additionally supports Product Classification and Regulatory Pathway and is available inside the General Notifications section.
Customizable dashboard: Users subscribed to Smart Exchange can now customize their dashboard with related listed features.
Country zoom in Resources map view: Small countries previously not visible in the default view can now be viewed with the automatic zoom functionality.
Virtual tour pop-up: A short cut to access the Virtual tour pop-up is now available under the account settings.
Service expiry pop-up: Notification are presented as a red banner above Headlines, as well as within the Marketplace dashboard, 20 days prior to service expiration.
Headlines and Featured Contents: The new headlines and featured contents now reflect the latest updates in the default dashboard.
Marketplace pages: Smart Builder was updated to accommodate new Mexico Equivalency Registration template. Quality Management System (e-QMS), also known as Greenlight Guru, was updated due to newly released features.
Team member permissions: Account owner can now grant access and assign relevant functionality to Regulatory Intelligence and Regulatory Pathway, if subscribed, to Team members.
Smart Builder (SB): Updated BR Registro templates with text/label changes and visibility rules. Updated content of blue help text in ‘GSPR’ node of MDR TDF and ‘Essential Requirements’ node of MDD TF builders. Users can access Smart Builder from dashboard and resources. Progress indicator updated to display previous export time to give users a sense of how long the current export is expected to take. Rearranged the tables so that content of the columns aligns with the width of the column. For MDD CER builder: updated text for ‘Device History’ section, logic updates to input/output specs, and output is more device specific in Appendix H. For MDR CER builder: logic updates to input/output specs, and output is more device specific in Appendix H. Removed section numbers from links in the list of nodes to avoid confusion with numbering for the user.
Smart Exchange: Users can now expand the Free Form Text Box. Improvement on +Add button functionality to add additional documents and submit for review. Updates in the Due Dates box in the SX Dashboard. "Soon" inside of the Due Dates box changed to "Pending." In pending state, all projects will appear - those due soon along with those past due. Admin can customize the auto-generated emails to add the account name and/or number of days left for review. Changed "Last Modified" to "Due Date" in Project Dashboard.
Product Classification: Design changes to improve process flow, consolidated Product Classification and Classification Rationale dashboard. View a classification summary, start a classification rationale report, and download a completed rational report all from your consolidated Product Classification dashboard.
Classification Rationale Reports: Updated rationale rules logic in general and as it relates to special rules.
Regulatory Pathway:
1. When purchasing a report user must double confirm the deduction of one (1) credit via a new pop up message. Message will also inform user of number of total and available credits remaining.
2. Once a report is purchased, user can download the report without using an additional credit.

Fixes

Notifications: Yellow bell icon can be seen for all notifications
Registration Tracker Reports: UI fixes
Pie chart view fixed for Smart Builder
Account Settings responsiveness for small screens improved
Product Classification and Classification Rationale reports: minor grammar fixes
SX was downloading as PPM files, but can now be downloaded and viewed in PDF
Smart Builder:
1. If you "Export to HTML" from Word and your table contains special characters, the characters now appear correctly when you "Import Table".
2. Image numbering is displayed correctly in Device Description node of 510(K) template.

Missing Label text in MDR CER - "Device Degree of Novelty, based on the Degrees of Novelty Card for a Medical Device" is added.

510(k) test results are available to link.

Known Issues

Email delivery failure for select domains still exist.
Overall Application responsiveness.
MDR Classification Rationale report: Page numbers are not continuous (page 14 missing) although no content is lost.

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December 04th, 2020 Release Notes

Introduction

Thank you for being a valuable customer of RAMS application. We are excited to announce the addition of more functionalities within Smart Builder, Notifications widget, Smart Exchange BETA version and new markets within Product Classification. Additionally, we are launching new premium services like Regulatory Pathway and Regulatory Intelligence. The following list outlines the four main sections of this document. Each section contains important information about the RAMS release. For detailed help instructions, please visit the RAMS Help Center.

What’s New

Updates/Improvements

Fixes

Known Issues

What’s New

➢ Smart Builder:

For all builders and projects, users with export permissions have the option to download submissions as a ZIP file containing the output of all nodes as individual PDF in the export area. Users have the option of viewing the submissions in PDF format using Adobe Acrobat. The PDF files can also be converted to MS Word using the “PDF Export” function of Adobe Acrobat DC or by opening the PDF files using MS Word.
Implemented Brazil Registro Materials and Equipment Builders: The user is guided in English to compile the Registro Technical File as well as the Letter of Authorization, if relevant, and Form Annex III.A. The user needs to engage a translator to provide certain fields translated in Portuguese. The Technical File is provided in both English and Portuguese based on the information entered by the user and translator. The Builder also helps the user to recognize what needs to be included as part of the Registro application. The export is a ZIP of separate PDF files.

➢ Regulatory Intelligence:

This new premium service now houses the Process Charts and Regulatory FAQs under its umbrella which were earlier available under Resources section in the left navigation menu of the RAMS application. Through this service you can access the valuable market intelligence resources.

➢ Regulatory Pathway:

EU MDR Regulatory Essentials reports based on device classification are available for immediate download on the Regulatory Pathway feature. The Regulatory Pathway helps to understand market regulations and requirements to plan organisation growth.

➢ Product Classification:

New Product Classification Dashboard for easy reference to completed device classifications and reports.
RAMS Product Classification has expanded to include New Zealand and Colombia.
User generated EU MDR Classification Rationale report available for immediate download.

➢ Virtual tour pop-up:

New and existing users who log in post 4-Dec.2020 will experience a virtual tour pop-up reviewing the features of RAMS. This quick tour showcases what is new with an option to skip and revisit any time from the RAMS Online Help.

➢ Service expiry pop-up:

When service expiration is within 1 month, notifications of the upcoming expiration will be displayed within the application. Notifications are presented as a red banner above Headlines, as well as within the Marketplace across each soon to be expiring service.

➢ Product Classification (BETA):

New Product Classification Dashboard for easy reference to completed device classifications and reports. RAMS Product Classification has expanded to include New Zealand and Colombia. User generated EU MDR Classification Rationale report available for immediate download.

➢ Two-factor authentication:

The RAMS application now includes enhanced security through a two-factor authentication mechanism enabled by the account owner. The account owner can set the address from which team members can safely access the RAMS application. If the RAMS account is accessed by an IP address not set, then the account owner will be notified via an email notification and can take appropriate action.

➢ Team member restriction notification:

If a team member access is restricted due to validity expiration then the account owner can will see them as blocked and can take appropriate action to renew access.

➢Smart Exchange:

Consultant Dashboard created, to consolidate all consultant projects into a single accessible site

Up-dates/Improvements

Notifications widget: The notification widget in the left panel now additionally supports Smart Builder and Smart Exchange notifications along with the existing Registration Tracker and Regulatory Intelligence.
Default dashboard: The notifications section of the main dashboard-notifications when customized now includes new services like Smart Builder and Smart Exchange notification updates.
Country zoom in Resources map view: Smaller islands or countries which were previously hard to locate can now be seen visibly by means of a default zoom option in place.
Notifications in account settings: Free trial & Subscribed Users can access the dashboard in the account settings and customize the notification preferences depending on active services like Smart Builder and Smart Exchange.
Marketplace pages: New information updates for Reg. Pathway, Smart Builder, Reg. Intel Product Classification sections.
Team member addition: The account owner can now add a team member to Product Classification and Regulatory Watch if subscribed and assign relevant access to attributes under them.
Team member/Service Downgrade notification available: If a downgrade of a service or team member value is performed then the user is notified appropriately.
Smart Builder (SB): For 510(k) builder “Performance Testing Bench Node,” the widget type has changed from Textbox to Image Text Table format so that the user has the option of including a table, text, or image.
Smart Exchange: SX now able to support drop-down boxes and combined document upload plus free form text box. Multiple contacts may now be included in the automatic SX Project email notifications. Due Date Dashboard sorted by date instead of project name; project status made clearer. SX now allows consultants to save their final deliverable for the client to review, directly in the project. General improvements for clarity: revised project status names, date stamp to remain static as of when a document was uploaded, and more.
Product Classification: Examples and explanatory text included on the Product Classification questionnaire to provide users with additional guidance.

Fixes

Resources: Dashboard viewing loading improvement
Registration Tracker Reports: UI fixes
Regulations & Guidance: Document downloading issue fixed
Alignment issues in Default dashboard page now fixed

Known Issues

Registration Tracker Reports are not fully responsive
Regulatory Watch count update in notification widget
In Resources map view we are unable to see the islands

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October 01st, 2020 Release Notes

Introduction

Thank you for being a valuable customer of RAMS application. We are excited to announce few more exciting additions within Smart Builder, Dashboard widget, Resources view, Smart Exchange BETA version and Product classification-New Markets. The following list outlines the four main sections of this document. Each section contains important information about the RAMS release. For detailed help instructions, please visit the RAMS Help Center.

What’s New

Updates/Improvements

Fixes

Known Issues

What’s New

➢ Customisable Dashboard

Users under free trial access and subscribed to services have the option to customise the dashboard from the standard view (default). The standard view has a featured content section to see What’s New and follow updates related to RAMS application

➢ Resources dashboard

The resources section now has 2 views namely map & list views to see the various resources and services offered in each country with options to switch between either of the 2 views.

➢ Role Based Access Control (RBAC)

The RAMS application now has the flexibility for various roles and permissions (policies) to be defined with the RBAC system in place at RAMS Account level and Project level applicable to Registration Tracker, Smart Builder & Smart Exchange.

➢ Smart Builder

IVDR TDF New Template, Multi language User Manuals for 510k, MDR TDF and MDD CER

➢ Product classification (BETA)

RAMS Product Classification has expanded to include four new markets (Australia, Singapore, Hong Kong & Malaysia)

The Product Classification service now includes an EU MDR Classification Rationale report option. Users can purchase an Emergo reviewed Rational Report (three to five-day turnaround) or a user generated report (one to three-day turnaround).

➢ Smart Exchange

New Feature in RAMS to allow clients to manage documents and get it approved by consultants, six project types supported.

Up-dates/Improvements

Notifications widget: The notification widget in the left panel now supports Regulatory Watch notifications.
Dashboard in account settings: Free trial & Subscribed Users can access the dashboard in the account settings and customize it depending on the active services. The dashboard notifications in the right panel shall now show notifications from both the Regulatory watch and Registration Tracker
Market place pages: Information updates done for Smart Builder and Product Classification sections based on the new updates.
Team member addition: The account admin can now add a team member to Registration Tracker/Smart Builder depending on the services subscribed and assign relevant access to features under them
Choose ac