Past Release Notes

RAMS Customer Release Notes

Release 2.24 October 10th , 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

Regulatory Process Charts:
- Process chart for new market “Sri Lanka” has been added with combined chart (Medical Device and IVD).

2. Updates or Improvements

Regulatory Reports:
- Updated regulatory reports of following markets:
  - Brazil
  - Canada
  - China
  - India
  - New Zealand
  - Mexico
  - Peru
  - Switzerland
  - United Kingdom
  - United States

Registration Tracker:

Bulk upload enhancements were made.
Users can now add up to 10 custom labels (optional) in a registration account. This option is provided in Step #4 of manual process.
A new tab “Deleted” has been added to the existing list of tabs, where all the list of deleted records are displayed with an option to restore the records.

Regulatory Process Charts:

“Canada” market’s process chart has been updated to combined chart (Medical Device and IVD).

Product Classification:

Users can now be able to download the classification summary.

Agreements:

New “Preview” option has been introduced to preview documents without having to download.

Smart Docs:

Enhancements were made to the category and sub-categories.
In individual service tab (Registration Tracker, Smart Builder, Smart Exchange and Agreements), “Share” option has been introduced to share the document with other users.
New “Preview” option has been introduced to preview documents without having to download.

Smart Builder

The following builders were updated to keep them latest & greatest:
- MDR TDF
- UK MDR TF
- IVDR TDF
- MDR CEP
- MDR CER

3. Bug Fixes

4. Known Issues

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RAMS Customer Release Notes

Release 2.23 June 20th , 2024

Introduction

What’s New
Updates or Improvements
Bug Fixes
Known Issues

1. What’s New

2. Updates or Improvements

Trainings:

A new training course, “European Vigilance for Medical Devices” has been added to the training module.

Regulatory Reports:

Updated regulatory reports of following markets:
- Brazil
- Colombia
- Hong Kong
- Israel
- Mexico
- New Zealand
- Singapore

Registration Tracker:

“Export All” option will export all the records of respective account and when search is applied, all the search results will be exported with “Export All”.
Uploaded files in Registration Tracker, can now be previewed.
While adding a record, a new option “Others” is introduced in “Device Class” field.
While adding a record, in “Record Type” field, where currently only “Other Records” option is present, a new drop-down option “Product Registration” is introduced.
Implemented bulk upload/attachment of maximum of 10 files to a maximum of 20 records at a time.

Regulatory Watch:

Regulatory article can now be shared (via link in an email) with colleagues from within Regulatory Watch module.

Representation Resources:

Product Listing Manager (PLM):
- Duplicate product family name will be allowed. However, within respective markets, duplicate of a combination of product family name and trade name will not be allowed.

Only Account Owners can now add or remove team members. Both Editor and Account Owners can purchase service through Marketplace.
Account Owner will no longer be able to change the permissions of other Account Owner.
Going forward, in-app notification will be sent to Account Owners 5 days prior to service expiry and the first 5 team members (irrespective of roles) will always be active.
User’s whose account has been restricted, can now be able to access (View/Download) freemium services.

Smart Docs:

In Smart Exchange page within Smart Docs, the search feature will be based on file name.
When a file is used from or in services (SB and SX), will have respective service mentioned in "RAMS Services" that the file is used in service (SB, SX, RT and Agreements).

Smart Builder

MDR CER:
- In Appendix B (Literature Search and Literature Review), in the “Import/Export Data section, XML file will also be accepted.
- In Appendix B (Literature Search and Literature Review), in the citations pop up, an option is provided to display all the rows that have blank field(s).
MDR CEP:
- The following question from MDR CER builder is now included in MDR CEP builder’s Node 1 (Cover Page). The selection made in the question will be included in Node 3 (Background) of the output.
  “Please select the following additional legislation, Common Specifications (CS), or guidance that is relevant to the medical device.”
BR Registro V2023:

- A new node “Modification History” – Node 11 has been included in the builder to track the history of modifications.
- User manual has been updated.
- ANVISA changes has been implemented as below:
  - In Node 2, new question “Is the medical device considered”. Based on the selection, the folder structure in the output has been modified accordingly.
  - In Node 3 (Technical Document), the changes are made to the following list of questions:
  - “Appendix title: Usability Report..”, has been modified to include question instead of file upload directly. User must select Yes/No option before uploading respective document.
- The following sections should be replaced with a Yes/No questions: Risk Management Report (Relatório de Gestão de Riscos) Is there a Risk Management Report associated with this device?
  1. Yes --> File upload widget (with File Name field)
  2. No ---> File upload widget (with File Name field) with label " Please provide a justification as to why there is no Risk Management Report associated with this device."
- Essential Requirements Checklist (Checklist de Requisitos Essenciais) Is there an Essential Requirements Checklist describing the safety and efficacy requirements of the product? GSPR (General Safety and Performance Requirements) is also acceptable.
  1. Yes --> File upload widget (with File Name field)
  2. No ---> File upload widget (with File Name field) with label " Please provide a justification as to why there is no Essential Requirements Checklist associated with this device."
- List of Technical Standards (Lista de Normas Técnicas) . Is there a list of technical standards and their respective versions considered in the development, design and production of the medical device?
  1. Yes --> File upload widget (with File Name field)
  2. No ---> File upload widget (with File Name field) with label " Please provide a justification as to why there is no list of Technical Standards associated with this device."
- Material/Chemical Characterization report(s) (Relatórios de caracterização material/química) Are there any reports describing the composition of materials for accessories and/or other parts of the equipment that come in contact with the patient (Certificate of Analysis of the raw material(s) that compose the device can be can also be provided)?
  1. Yes --> File upload widget (with File Name field)
  2. No ---> File upload widget (with File Name field) with label " Please provide a justification as to why there is no Material/Chemical Characterization report(s) associated with this device."
- Certificate of Analysis of the Raw Material (Certificado de Análise da Matéria-Prima) Is there a Certificate of Analysis of the raw material that compose the device (MSDS can also be provided)?
  1. Yes --> File upload widget (with File Name field)
  2. No ---> File upload widget (with File Name field) with label " Please provide a justification as to why there is no Certificate of Analysis of the Raw Material associated with this device."
- Biocompatibility Assessment Biological assessment reports (Avaliação da biocompatibilidade Relatórios de avaliação biológica) Are there any reports including pyrogenicity and residual toxicity studies, where applicable, according to ISO 10993? If any standard of ISO 10993-Series is not applicable, provide rationale justification for such decision. This item is applicable for all parts of the device that contact the user, patient, etc.
  1. Yes --> File upload widget (with File Name field)
  2. No ---> File upload widget (with File Name field) with label " Please provide a justification as to why there are no Biocompatibility Assessment Biological assessment reports associated with this device."
- Certificate of Analysis of the Finished Product (Certificado de Análise do Produto Acabado) Is there a certificate of analysis of the finished device (final release) associated with this device?
  1. Yes --> File upload widget (with File Name field)
  2. No ---> File upload widget (with File Name field) with label " Please provide a justification as to why there is no Certificate of Analysis of the Finished Product associated with this device."
- Sterilization Validation report (Validação da Esterilização) Is there a Sterilization Validation report associated with this device?
  1. Yes --> File upload widget (with File Name field)
  2. No ---> File upload widget (with File Name field) with label " Please provide a justification as to why there is no Sterilization Validation report associated with this device."
- Usability report (Relatório de Usabilidade) Is there a Usability report associated with this device?
  1. Yes --> File upload widget (with File Name field)
  2. No ---> File upload widget (with File Name field) with label " Please provide a justification as to why there is no Usability report associated with this device."
- Drawings (Desenhos Técnicos) Are there any Engineering drawings associated with this device?
  1. Engineering Yes --> File upload widget (with File Name field)
  2. No ---> File upload widget (with File Name field) with label " Please provide a justification as to why there is no Engineering Drawings associated with this device."
- Added both Portuguese and English versions in Summary/Index.
- The question “Upload cleaning and/or disinfecting protocol” has been removed as it had not relevance to the output.
- The folder “04DT-CER” will include all the uploaded files instead of being included in the sub folders.

Smart Exchange

In template #58 - MDR Transition Review - EU/UK/CH/AUS - MDR Transition Extension, “MDR Classification” section has been made optional.
In template #59 - UKRP - MHRA Device Registration - UK - Product Registration - MD/IVD/AIMD, following changes have been implemented:
- The drop-down options for the question “Will you be submitting additional device registration forms?" is updated as below:
  - Yes, I have additional products to register.
  - No, this is the only/last registration I’m submitting.
  - By selecting Yes, a new project is automatically created.

3. Bug Fixes

Fixed the bug of users navigating to “Australia” market by default in Product Listing Manager. Users will now be navigated to the respective market tab.
In Smart Docs, the files uploaded via “Smart Docs” option from Smart Builder, Smart Exchange, Agreements and Registration Tracker services, were not visible. This has been resolved.
Postproduction release, the slowness issues during application loading has been resolved.
Preservice expiry email which was triggering twice has been resolved.
While renewing the service from Emergo Pro to Emergo Plus the issue of having designated number of team members has been resolved.

4. Known Issues

In Smart Docs, the search functionality is case sensitive.

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RAMS Customer Release Notes

Release 2.22 March 14th , 2024

Introduction

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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