Firmware Validation Protocol/template - FDA regulated Medical Devices industry

M

Medsearch

#1
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
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
Re: Firmware Validation Protocol/template

Can any medical device folks help with this one?
 

Stijloor

Staff member
Super Moderator
#3
Re: Firmware Validation Protocol/template

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.
 
G

Gert Sorensen

#5
Can you please describe your product a bit more. That will help us give input on the subject. :bigwave:
 
R

Ronaldinho

#6
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!!!
 
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