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
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