Software Validation (as part of your QMS, for the ISO 13485)
Dr. Oliver Eidel
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IEC 62304: Medical Device Software Development
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Published December 03, 2025
Let's take a look at how to validate software in the context of the ISO 13485. First, we'll look at the SOP.
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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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