Clinical Evaluation: The Clinical Evaluation Report (CER)
Dr. Oliver Eidel
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IEC 62304: Medical Device Software Development
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Published December 22, 2025
You need to document and demonstrate the clinical evidence for your software. In this video we will see how to fill out the Clinical Evaluation Report (CER) template.
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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