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How do we show our Software Develoment Life Cycle is similar to IEC 62304

R

regmeddevices

#1
We have a Class II software device (regulation 21 CFR 892.2050) and intended to be used by dentists.


Our Software development life cycle (SDLC) is similar to waterfall and IEC 62304 but not in 100% compliance with IEC 62304 and we cannot submit a declaration of conformance with IEC 62304. Should we demonstrate in our document at several places that our SDLC is similar to waterfall and follows IEC 62304.

Thanks
 
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yodon

Staff member
Super Moderator
#2
Sounds like it would be misleading to me.

To what aspect(s) are you not compliant? I don't find 62304 to be prescriptive in terms of WHAT the SDLC (methodology; e.g., waterfall, agile, iterative, etc.) is, only that you define it. Of course, there are plenty of expectations built in but these are, IMO, pretty much standard software development practices.
 
R

regmeddevices

#3
Okay I think I did not communicate properly here. I'm more concerned about how we can be in compliance with IEC 62304.

So actually we can sign declaration of conformance with IEC 62304 if we can give details about every requirement of IEC 62304, for example, Under Software maintenance PROCESS we give details of Establishment of software maintenance plan, Problem and modification analysis and Modification implementation. It that right? Please correct me if I'm wrong
 

yodon

Staff member
Super Moderator
#4
Of course, you must (be able to) show objective evidence to be in compliance with the standard. That's true for being in compliance withany standard.

Signing a DoC is more of a regulatory action. I don't know what (else) would be required to do so.
 
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