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 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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