Post Market Clinical Follow-up: The Report (Medical Device Clinical Evaluation)
Dr. Oliver Eidel
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IEC 62304: Medical Device Software Development
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Published December 26, 2025
After making a plan you need to summarize your PMCF data in the CER. We will see how to do that and which choices you have.
Looking for an eQMS software for medical device compliance? Check out our eQMS, Formwork, the best eQMS for lean, founder-led companies:
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Looking for an eQMS software for medical device compliance? Check out our eQMS, Formwork, the best eQMS for lean, founder-led companies:
https://openregulatory.com/
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I’m a medical doctor, software engineer and regulatory dude. I’m also the founder of OpenRegulatory.
Through OpenRegulatory, I’ve helped 100+ companies with their medical device compliance. While it’s also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)
If you’re still lost and have further questions, reach out any time!
Through OpenRegulatory, I’ve helped 100+ companies with their medical device compliance. While it’s also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)
If you’re still lost and have further questions, reach out any time!
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