- Introduction (00:01:05)
- Why Learn About PMCF (00:02:29)
- PMCF Plan Contents (00:01:00)
- Post-Market Clinical Study (00:02:48)
- Post-Market Clinical Follow-Up (00:02:16)
- Meditrial can help you (00:00:42)
Post-Market Clinical Follow-Up
This lecture describes the key changes regarding post market clinical follow-up and what companies should do to meet their new obligations. After the course you can take a final test to receive your certification. Enjoy!
Why take this course
This Meditrial Video Lecture By Dr Monica Tocchi is designed to help gain detailed knowledge of implementing your PMCF procedure, applying the requirements listed in Annex III/IV, and understanding whats new in the MDR for PMCF and PMS.
What I will learn
- Post-Market Clinical Follow-up (or PMCF)
- MDR Scope and Definitions
Skills I will gain
- Understand PMCF and PMS and their relevance for medical device assessment
- Explore PMCF study design and approval
- Gain thorough knowledge of PMCF, risk management and labeling
- Understand PMCF and it relates to the clinical evaluation
- Final Test – Post-Market Clinical Follow-Up
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