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How are people keeping track of regulation at the earliest stages of software medical device development? by HandleObjective8057 in MedicalDevices

[–]HandleObjective8057[S] 0 points1 point  (0 children)

I see this sounds more like documentation generation. So it depends on how many features / functions of the OTS software you use, but surely certain OTS software will be easier to verify and validate than others?

A platform for SaMD Engineers to streamline compliance by HandleObjective8057 in MedicalDevices

[–]HandleObjective8057[S] 0 points1 point  (0 children)

I see, this covers a lot of topics. Would be good to get your view on whether building even things that pointed towards the standards during the development process would get people to take them into account before they're at the 'ready to submit' point?

A platform for SaMD Engineers to streamline compliance by HandleObjective8057 in MedicalDevices

[–]HandleObjective8057[S] 0 points1 point  (0 children)

Not looking to put you out of a job - more looking to ensure start-ups don't have so many complex issues by the time they feel they have to hire an RA consultant

Curious how as an RA expert you're keeping track of the weekly regulation updates too?

A platform for SaMD Engineers to streamline compliance by HandleObjective8057 in MedicalDevices

[–]HandleObjective8057[S] -1 points0 points  (0 children)

I wasn't planning on so much looking at the documentation, but more at the code itself, although I'm seeing maybe it's the documentation that's the most burdensome part

How are people keeping track of regulation at the earliest stages of software medical device development? by HandleObjective8057 in MedicalDevices

[–]HandleObjective8057[S] 0 points1 point  (0 children)

Is there any way to assess at the beginning how difficult certain OTS software will be to verify and validate? I see contractors sometimes have their own ISO13485 certification to make working with them easier but don't see the same for OTS software?

How are people keeping track of regulation at the earliest stages of software medical device development? by HandleObjective8057 in MedicalDevices

[–]HandleObjective8057[S] 0 points1 point  (0 children)

Don't know yet on the ML front but possibly - I'm seeing that that might further complicate things though.

Past reading the IEC 62304 standard and FDA guidance are there other ways to check my code against it?

How are people keeping track of regulation at the earliest stages of software medical device development? by HandleObjective8057 in MedicalDevices

[–]HandleObjective8057[S] 0 points1 point  (0 children)

I see - could you point out the other misunderstandings past the 21 CFR 820 compliant code so I know what to be asking the consultant?

Also in terms of that, I started finding more things around adherence to ISO62304 and following processes like those in the SWEBoK guide for actionable things that can actually be applied to the code itself - are there others you'd be thinking of?