Does the V&V (Verification and Validation) belong to Bench Testing for 510k?

A

asadr

Hello cove-people

We have a class 2 light therapy device for traditional 510k. For bench testing section 18 we have including our system spec, V&V, Risk analysis, trace matrix (BTW we software at low level of concern)

Is this the proper domain for these documents? should we just leave bench testing blank, put the V&V and trace matrix in our software section 16?

or

Should we make 510k dedicated engineering test reports?

What is the convention for this section? (we do have technical characteristics and safety features which are vetted via consensus standard testing)

warm regards
 

Stijloor

Leader
Super Moderator
Hello cove-people

We have a class 2 light therapy device for traditional 510k. For bench testing section 18 we have including our system spec, V&V, Risk analysis, trace matrix (BTW we software at low level of concern)

Is this the proper domain for these documents? should we just leave bench testing blank, put the V&V and trace matrix in our software section 16?

or

Should we make 510k dedicated engineering test reports?

What is the convention for this section? (we do have technical characteristics and safety features which are vetted via consensus standard testing)

warm regards

Can someone help?

Thank you!!

Stijloor.
 

Ronen E

Problem Solver
Moderator
Hello cove-people

We have a class 2 light therapy device for traditional 510k. For bench testing section 18 we have including our system spec, V&V, Risk analysis, trace matrix (BTW we software at low level of concern)

Is this the proper domain for these documents? should we just leave bench testing blank, put the V&V and trace matrix in our software section 16?

or

Should we make 510k dedicated engineering test reports?

What is the convention for this section? (we do have technical characteristics and safety features which are vetted via consensus standard testing)

warm regards

It's not that important.

If adequate content is there, format & editing are negotiable. At worst, the examiner will note that they didn't find whatever they were expecting under section "X", and you would then point to where it is (I doubt it will get to that, but for argument sake...).

I wouldn't include under "Bench Testing" any thing that is not bench testing, let alone anything that is not testing. from the entire list quoted, I tend to think only V&V testing is relevant to that header. Further, if I had the test results available but no appropriate test report then yes, I would compile one dedicated to the 510k submission.

My :2cents:

Cheers,
Ronen.
 
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