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Agile Development For Medical Device Software: Is It Possible?

Dr. Oliver Eidel • Software as a Medical Device • Updated May 19, 2024 • Agile Development

This is the million-dollar question, or the Holy Grail of medical device compliance: Can you do agile development which magically generates all the necessary compliance documentation for your audits? I'll walk you through what's needed for passing audits, and based on a typical agile development process (ours!), we can take a look at whether it's possible.

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Can We Do Agile Development For Our Medical Device Software?

updated about 1 year ago

We want to do agile development. Can we do agile development for our medical device software?

Dr. Oliver Eidel

Accepted answer

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Dr. Oliver Eidel

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!