SOP for software validation of software in medical device IEC 62304

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yodon

Staff member
Super Moderator
#2
There's not much that's "SOP-worthy" regarding software validation specifically. We just incorporate those aspects under our Software Development Lifecycle SOP - which is aligned with IEC 62304. That SOP is going to be tailored specifically to your software operations so it's unlikely that anyone else's SOP is going to be all that useful.
 
B

BhupinderSinghPawa

#4
I am assuming that you have a software development process compliant to EN IEC 62304. The standard does not cover software validation. The activities for unit - integration - 'software' system testing corresponds to software verification.

Here in the FDA guidance on software validation is useful. The software validation can be articulated as sum total of software verification activities and subsequent system validation (of which software is a constituent) that proves that the product / verified software meets its intended use.

This may be included in SOP's for product and software development.
 

racglobal

Involved In Discussions
#6
I think you are looking at your design history file, rather than a general QMS SOP for validation. It's product specific. And you are looking at your design file, rather than the general QMS.
 
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