What does the Medical Device Regulation (MDR) tell us about Post-Market Surveillance?

With the Medical Device Regulation (MDR) coming into full force in 2021, 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 whitepaper will address the role of Post-Market Surveillance during the lifecycle of your device, the specific requirements for Post-Market Surveillance under the MDR, and how an EDC system can help you fulfill these requirements in a cost-effective way.