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.

We will cover:

  1. The role of Post-Market Surveillance during the lifecycle of your device.
  2. The specific requirements for Post-Market Surveillance under the MDR.
  3. How an Electronic Data Capture (EDC) system can help you fulfill these requirements in a cost-effective way.
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