System Verification & Validation in HC Class III Submission

shimonv

shimonv

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#1
#1
Hi Everyone,
I can see in HC guidance documents that software has its own section (section 11.6 according to STED format) and that manufacturers usually includes standards test results in the general section (section 11.1), but what about system V&V? or is it not to be included?

Thanks,
Shimon
 
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shimonv

shimonv

Trusted Information Resource
#3
#3
In attempting to answer my own question:
While software has its own section in the submission that includes all the V&V documents (requirements, test plan, test report, traceability matrix,etc.), there is no explicit requirements to do the same for dedicated hardware that makes for a system together with the software.

The way I figure it, if one includes the SW and HW requirements in the section 7.2 (according to STED format) and external lab reports such as electrical safety and EMC in section 11.1 it should be fine. Again, there is no requirement to include HW or System V&V plan and report with the submission.

If someone learned otherwise, please share.
I will soon make the submission. When I learn something new I will share.

Best,
Shimon
 
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