Case Study

What does the MDR tell us about post-market surveillance.

What does the MDR tell us about post-market surveillance.

Pages 6 Pages

August 2018 White Paper What does the MDR tell us about post-market surveillance. Author: Matthias Havenaarcastoredc.com | What does the MDR tell us about post-market surveillance. 2 Faster, smarter medical research. With the Medical Device Regulation (MDR) coming into full force in 2020, medical device companies should prepare for tougher Post-Market Surveillance (PMS) requirements. Companies will need to update their PMS procedures and should budget for more Post-Market Clinical Follow-up (PMCF) studies. This article will address the role of PMS during the lifecycle of your device, the specific requirements for PMS under the MDR, and how an EDC system can help you fulfill these requirements in a cost-effective way. 1. What is the role of post-market surveillance during the l

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