Ultimate Guide EU MDR GSPR

Read: Your Guide to the EU MDR General Safety and Performance Requirements (GSPR)

With the European Medical Device Regulation (MDR) looming, medical device companies are focusing on ensuring compliance with the new regulations. One of those key aspects of compliance is to ensure your devices conform to the General Safety and Performance Requirements (GSPR). Read this free guide for practical guidance on how to meet those requirements.

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MDSAP: The Ultimate Guide to the Medical Device Single Audit Program

The MDSAP was designed to allow a single audit of a medical device manufacturer to be applied to all country markets whose regulatory authorities are members of the program. A report from a single MDSAP audit is an accepted substitute for routine inspections by all the member Regulatory Authorities across the world.

Rimsys joins MedTech Europe

This week Rimsys became an associate member of MedTech Europe, the European trade association representing the medtech industry. As a member of the organization, we’ll have visibility into regulatory changes across the region as they’re being formed, and the opportunity to shape how those regulations are implemented.

Better Together: Regulatory Intelligence and Regulatory Information Management

Today we announced a new partnership with Clarivate to bring together regulatory intelligence from Clarivate Cortellis with regulatory information management from the Rimsys Platform. This combined offering will allow RA professionals to access 200k+ regulatory documents from over 80 countries, and harness insights directly in automated processes.

FDA 510(k): A Beginners Guide

eBook excerpt - Congratulations! You have successfully developed a new medical device. Now you need to take it to market. In the United States, this often means submitting a 510(k). A 510(k) is a structured package of information about your device and its performance and safety that you submit to the Food and Drug Administration (FDA).

EUDAMED and UDI in Europe: An Overview

The European Databank on Medical Devices (EUDAMED) is an IT system developed by the European Commission to increase transparency and improve surveillance of medical devices (and in vitro diagnostics) that are sold within the European Union.

Tackling regulatory continuity: How regulatory affairs teams can use technology to reduce the impact of employee turnover

A significant challenge that medtech companies have to manage is that of continuity. Perhaps due to the challenges of the job, turnover among regulatory affairs (RA) professionals is surprisingly high. RA professionals at all levels average less than 3 years in their jobs. All of this turnover leads to two acute problems.