With the Medical Device Regulation (MDR) coming into full force in 2021, companies should prepare for tougher requirements for Post-Market Surveillance (PMS) of medical device data. 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.
We will cover:
- The role of Post-Market Surveillance during the lifecycle of your device.
- The specific requirements for Post-Market Surveillance under the MDR.
- How an Electronic Data Capture (EDC) system can help you fulfill these requirements in a cost-effective way.
