Regulatory Operations within the Medical Device industry are going through an unprecedented and revolutionary change. This transformation is driven largely by global regulatory agencies now requiring data-driven submission content and a shift towards standardization of technical documentation structures. Coupled with increasingly globalized distribution networks, this move has exponentially increased the volume and complexity of submission content that must be kept consistent and up to date to manage global registrations.

Historically, Regulatory Professionals within the Medical Device community have not had access to software solutions designed to meet their specific needs. This resulted in organizations managing and tracking information across multiple spreadsheets and cross-referencing files in document management systems leading to a cumbersome, error-prone, complicated, and expensive process.

Until now, the solutions available to Regulatory Professionals addressed just a small selection of regulatory functions. This resulted in tools that only supported a few industry needs or required large integration and maintenance investments to make them fit for purpose.


Samarind RMS Medical Device Detail


 

Your Single Place of Truth™ for Regulatory Information

 

 

Imagine the operational efficiencies and confidence in regulatory information that can be achieved through managing and automating data flows within one system, with prebuilt data structures for all your products, product families, registrations, economic operators, documents, health authority interactions, and regulatory change management within a single global deployment.

This would mean – no more regionally disparate Excel workbooks, disconnected regional workflows, data redundancy, elimination of data reverification and aggregation. Increasing confidence in your submission content and allowing more time to pursue strategic regulatory initiatives.

 



Samarind RMS Features

  • A MedDev database with pre-built data structures required for compliance with global regulatory requirements
  • FDA UDI, EUDAMED, and IMDRF dossiers support for devices and IVDs
  • Automated data flows between related entities
  • Templates for dossiers, documents, data attributes and change management workflows
  • Project planning and management tools to support regulatory interactions and change management
  • Renewal and deadline tracking with automated notifications, alerts, and dashboards

 


Key Benefits

  • Increase market availability of your product portfolio
  • Ensure compliance with evolving regulatory requirements
  • Achieve significant improvements in operational efficiencies
  • Reduce time to submissions
  • Improve confidence in submission data
  • Minimize resources spent on verification and remediation
  • Increase visibility into regulatory performance metrics
  • Drive cost-functional change management
  • Leverage regulatory data as a corporate asset

RIM Resources

A monthly medical devices blog for today's regulatory professional

Visit the blog

Get a better handle on Global UDI compliance in an increasingly complex environment

Watch the webinar

The most efficient, practical and cost-effective way to manage all regulatory information in one place

Download the fact sheet

Leverage technology solutions to improve regulatory operations information management

Watch the webinar

The most efficient, practical and cost-effective way to manage all regulatory information in one place

Download the fact sheet