Firmware Validation Protocol/template - FDA regulated Medical Devices industry

[Medsearch]

I am working in a FDA regulated medical devices industry, we would like to validate our firmware version of our device.

Can anyone please share the validation protocol/ template or model validation report samples

[Marc]

Can any medical device folks help with this one?

[Stijloor]

In Reply to Parent Post by Medsearch

I am working in a FDA regulated medical devices industry, we would like to validate our firmware version of our device.

Can anyone please share the validation protocol/ template or model validation report samples

Bump.

Stijloor.

[harry]

I am not sure if the discussions in this thread would provide you with some ideas: Is firmware or embedded software subject to the same standards as software?

[Gert Sorensen]

Can you please describe your product a bit more. That will help us give input on the subject.

[Ronaldinho]

Hi, first of all you should review GAMP 5 for CSV; 2nd: you should be able to revert and review all of the documentation that preceded the development of said hardware/software design ie. SDLC, req analysis, software requirements and user and functional specifications etc; not necessarily in this order, but you get the picture!!!