Hello,
I am preparing the technical file for the class IIb device which is diagnosis device. I have some confusion on preparing Product verification document.
What will be the level of product verification document for class IIb device??
Do I need to conduct verification till the component level requirement?? or is it sufficient to provide the verification document on higher level (system level) requirement??
And what will be the level for software verification and validation??
Is it possible to combine the product and software verification and validation document or we need to prepare separate document?
I am preparing the technical file for the class IIb device which is diagnosis device. I have some confusion on preparing Product verification document.
What will be the level of product verification document for class IIb device??
Do I need to conduct verification till the component level requirement?? or is it sufficient to provide the verification document on higher level (system level) requirement??
And what will be the level for software verification and validation??
Is it possible to combine the product and software verification and validation document or we need to prepare separate document?