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Level of details required for Class IIb Product Verification and Validation

#1
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?
 
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yodon

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#2
If your device is making a diagnosis, the bar will be set pretty high. To state the "level" required is not very easy to describe. There are multiple factors contributing. You typically start with a set of User / Customer requirements (user needs / intended use) to form the basis for validation. These are then translated into system requirements which are typically "engineering's answer" to the user needs. (There is traceability between user needs and system requirements). You will also need a risk analysis. The controls identified in the risk analysis must be managed as requirements and eventually verified. There are also harmonized standards your device will be expected to meet (e.g., IEC 60601-1, etc.).

Regarding software, the IEC 62304 standard is harmonized so you can use that as the guidance for developing your software testing.

There will quite likely be overlap between product and software verification. Frequently, though, you will need software-specific tests.
 
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