Technical Documentation 1 answer

Can We Use GitHub and Other SaaS For Our Software as a Medical Device?

Anonymous · Updated May 08, 2024
We’re currently using SaaS tools like GitHub to host our code. Our consultant told us that that’s not okay and we need to self-host everything. His reason was that we’re only allowed to use tools which we can “validate” ourselves. That would mean that any third-party-hosted software like GitHub would be prohibited. Help!

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1 Answer

Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
Your consultant is wrong. You can use GitHub. And look for another consultant.

Long Answer

The ISO 13485 requires you to “validate” all quality-relevant software prior to use. That applies to GitHub, too. The fact that GitHub is hosted somewhere else and you don’t have full control over it is not a problem per se. You should just write down some sort of explanation why you’re okay with that.

The most obvious line of reasoning would be this: The availability of third-party-hosted software like GitHub is much higher if they take care of the hosting. So, it’s a good thing. On the other hand, what would the risks be? Data gets leaked or you lose access to the service, e.g. because you live in a country which is affected by U.S. export bans.

Include those points in your software validation and you’re good to go. See this answer to a similar question for a more in-depth explanation of what to.

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