RAMS Customer Release Notes

Release 2.29                                                                                                                                                     May 27th, 2026


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 be more secure, let you access the latest regulations. 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. 

  1. What’s New
  2. Updates or Improvements
  3. Bug Fixes
  4. Known Issues

 

 

1. What’s New

  • Tools: 
    • Review Time Estimate:
      • Introduced to provide information on average government and third-party review times for various registration and submission types worldwide.
         
  •  Representation Resources:
    • Service Newsletters: 
      • Introduced Service Newsletters to deliver market specific regulatory updates and service information exclusively for In-Country representation clients.
         

 

 
2. Updates or Improvements 

  • Regulatory Reports: 
    • Updated regulatory reports for:
      • Canada
      • India
      • Taiwan
      • UK
         
  • Regulatory Watch:
    • The following details have been added in the Regulatory watch email notification that is sent when an article is added:
      • Effective Date 
      • Published Date 
  • Profile image size has been limited to 5 MB and only “JPEG” and “PNG” formats are allowed. 
  • During RAMS production deployment (release), all the active users who are logged into the application will be logged out and access to RAMS application will be restricted until the deployment is completed. 
    • The following message will be displayed when a user tries to login into RAMS application.
      "Access to RAMS application is temporarily restricted as scheduled maintenance is in progress. The application will be available by HH:MM GMT." 
  • Tools:
    • Government Fee Finder:
      • A new category “Digital Medical Device” has been added and applicable ONLY to the country "South Korea". 
  • Agreements:
    • For Australia market, the "Document Type", "Addendum - Prosthesis List" has been changed to "Addendum - Prescribed List".
    • For market "United States of America", for all the document type options, prefix "US Agent" has been added.
       

Smart Builder

  • Following new markets are introduced for MX Equivalence Builder:
    • Australia
    • Japan
    • Switzerland
    • UK
    • Europe (IVDR)
    • Singapore
  • In Software as Medical Device (SaMD) projects, the following changes are made:
    • Under prompt "Art. 262 of LGS and Pharmacopoeia based Device Category", a new category has been added as seventh radio button called as “VII. Other health supplies as medical devices (Software as a Medical Device)”
      • This will be printed on the output file as:
         “VII. Otros insumos como Dispositivos médicos (Software como dispositivo Médico)”
    • In Node 8, the following prompt was changed:
      “Upload Software Requirement Specification docume      nt.” to “Upload Device Description and Software Requirement Specification document.”
       

Smart Exchange  

  • Completeness Review Form:
    • In the “Completeness Review Form”, when later comments are added, the initial comments are made to be cleared. 
    • In the comment’s widget, all the comments are made visible.
    • In DoC section, the following 3 questions are removed:
      • “Is the manufacturer name and address, correct?”
      • “Is the Rep name and address listed (if applicable)?”
      • “Is the NB name and number as well as the certificate number listed (if applicable)?”
    • The following 2 questions are merged to one question as “Are the devices uniquely identified (product name, code or unambiguous identifier) and are names consistent across documentation (PLM/Request form, DoC, Certificates, Labels)?” with response options “Yes” and “No”.
      • “Are the devices uniquely identified (product name, code or unambiguous identifier)?
         “Are the device family and trade names consistent across documentation (PLM/Request form, Doc, Certificates, Labels)?”
      • This change would apply to new projects ONLY. 
    • In the PDF form, client name (company) has been added in "Class B - Europe - ANY - Completeness Review Form". 
  • Status will be displayed at the top right section where project details are displayed.
  • When the project is in “Upload in Progress” status, and hovered over on the “Save” button, the following message would be displayed:
     “Project details have been saved. The Save option will reactivate if any section is edited. All required sections must be completed and saved before submitting the review to the consultant.”
  • When a section is in "Needs Client Revision" status, the "No upload, just comment" has been removed and a note would be displayed as below:
     "Please review and address the consultant’s concerns noted in the comments, if you believe the information provided is already correct, a revised document does not need to be uploaded."
  • The acknowledge check box has been removed from the following sections of new projects:
    • Person Responsible for Regulatory Requirements
    • Manufacturer’s Self Declaration
    • Notified Body Issued Letter
    • Classification Rationale Statement
    • Notified Body issued CE Certificate/ in some templates identified as "EC/DE Certificate(s)"
    • Design Examination Certificate
    • DoC/in some templates identified as "Signed Declaration(s) of Conformity (DoC)"
    • IFU
    • Labels
    • GSPR/ERC
    • Risk Management Report (or Summary)
    • CER/PER
    • Vigilance Procedure
    • PMSP
    • IGJ Notification Questionnaire
    • EUDAMED registration of Devices
  • "Request for Addition of Products Form" section has been removed from the following template related projects:
    • UKCA-Class I MD Self-Certified
    • UKCA-Class IS/IM/IIa/IIb/III MD
    • General IVD
    • IVD-List A/List B/Self-test
    • IVDR - Class A
    • IVDR - Class A Sterile/Class B/C/D
    • IVDR_Class A Sterile/Class B/C/D
    • Procedure Pack (Art.12 MDD or Art. 22 MDR)
    • QuickReview
  • The following modifications were made in IGJ section and applied to the existing section.
    • Users will be able to upload files to this section. 
    • The new IGJ section will be removed from all the templates/projects.
  • When the required section(s) are pending/incomplete and tried to submit the project, system will display incomplete section(s).
  • The verbiage below must be added to the PDF file that can be downloaded upon completion of the review.
  • The verbiage below has been added to all the PDF files at the bottom of the file. 

            “LEGAL DISCLAIMER: EMERGO DOES NOT MAKE AND HEREBY SPECIFICALLY DISCLAIMS ALL                                     WARRANTIES, EXPRESS OR IMPLIED, AND AS MAY ARISE BY OPERATION OF LAW OR BY STATUTE, WITH                 RESPECT TO THE SOURCES AND CONTENT OF THIS REPORT. THIS DISCLAIMER INCLUDES, WITHOUT                     LIMITATION, A DISCLAIMER OF ANY WARRANTY OF NON-INFRINGEMENT AND A DISCLAIMER OF ANY                         WARRANTY OF FITNESS OR SUITABILITY OF THE REPORT FOR A PARTICULAR PURPOSE. THE RECIPIENT              OF THIS REPORT AGREES THAT THE REPORT IS FURNISHED WITHOUT RESPONSIBILITY OR LIABILITY BY               EMERGO FOR ANY INJURY, DAMAGE, OR OTHER LOSS THAT THE RECIPIENT MAY INCUR.”

  • The verbiage will be added to all the templates related projects.

 

 

3. Bug Fixes

  • N/A 

 


 4. Known Issues

  • N/A