IEC 62304 - Compliant Software Requirements Specification For Software as a Medical Device (SaMD)
Dr. Oliver Eidel
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Clinical Evaluation
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Published May 24, 2022
When developing software as a medical device (SaMD), you have to document something called "Software Requirements". That's an ancient term for describing your software features. And there's a standard for that, the IEC 62304 (a lengthy PDF document) which tells you how you document those.
Confused? The good news is that we've developed a software which helps you document those requirements in a compliant way. Watch this video to learn more! :)
Are you interested in shipping your medical software faster? Check out Formwork:
https://openregulatory.com/
Confused? The good news is that we've developed a software which helps you document those requirements in a compliant way. Watch this video to learn more! :)
Are you interested in shipping your medical software faster? Check out Formwork:
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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