Product Portfolio & Country Registrations Management

For MedTech

Easy to Use and Deploy. Fast, Robust, Scalable and Secure solution

Off-The-Shelf module for MedTech manufacturers, developers, actors & stakeholders, a secure, private repository and cloud database to keep track of their Portfolio, Actors and Registrations in all Countries around the globe. This module keeps track of key information to have all information up to date in a centralized and secure location where any member of your company can access to any time. 

Product Portfolio

Keep your products and related information under control with this module

  • Portfolio Management of Product Codes: Build and Manage your Portfolio automatically by Family, Basic UDI and Product Code 
  • Organization by Product Codes-SKUs, Product Families & Basic UDI-DIs.
    • More than 25 attributes per Product Code, fields include UDI requirements in USA and EU. Add information and notes related to your product.
    • Country Registrations by Product Code, by Certificate and by Product Family. Link Product Codes to Registrations automatically
  • Regulatory Impact Reporting by Product Code, Product Families and Basic UDI-DIs.
    • Integration with Regulatory News Systematic Reviews and Impact Assessments
  • Ability to add Registration directly from existing Product Codes.

Provide visibility, easy access to information, and traceability about your products to the organization.

Country Operators

This module makes the process of keeping up to date with the rest of operators very easy

  • Country Operators roles (Legal Manufacturers, Distributors, Importers, Country Representatives, Relabeler, etc.)
  • Establishment Registrations, Contracts & Licenses Management
  • Documents upload by establishment and certificate
  • Notes, Activities, and many more functions.
  • Assignment of priority, deadline and responsible user.

Build the operators relationships, roles and deadlines applicable to your organization at global scale and/or by country.

Country Registrations & Certificates

Automatically combines information to organize information by country, certificate and product, alongside with numerous functions and features, to easily manage and view the information.

  • Country Product Certificates Management
    • Certificates List from all countries
    • Documents upload by country certificate
    • Notes, Activities, and many more functions.
    • Assignment of priority, deadline and responsible user.
  • Country Product Registrations Management
    • Visualization of all registrations in all countries
    • Visualization of registrations by Country and expiration
    • Distributor and Country Representative Assignment
    • Organization of registrations by Country
  • Country Representative and Distributor fields
  • Renewal Management for Certificates, Registrations & Establishments
    • Assignment of priority, alert time and responsible user.
    • Ability to filter expiring registrations by time periods.
  • Selling Yes/No field for regulatory flags and shipping

Powerful, Real Time, and Continuously Organized, information ready and secure for any member of your organization, from Regulatory, to Marketing, Commercial and Clinical.


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