Software Detailed Design Documentation in Formwork
Dr. Oliver Eidel
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Clinical Evaluation
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Published April 08, 2024
If you're IEC 62304 class C (there are classes A, B and C), you need to document something called "software detailed design" for your medical device. Let's check out how you can document that in Formwork, our QMS software.
Check out Formwork here:
https://openregulatory.com/
Check out Formwork here:
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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