Current Release Notes

RAMS Customer Release Notes

Release 2.23 June 20th , 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:

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
- Taiwan

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.