Post-Market Surveillance: The Periodic Safety Update Report (PSUR)
Dr. Oliver Eidel
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IEC 62304: Medical Device Software Development
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Published December 30, 2025
No plan without a report. Depending on your risk class you create a PMS Report or a PSUR. The differences, structures and a helpful MDCG Guidance - all in one video.
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/
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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