Seeking Guidance Verification Test Strategy for Class B Medical Devices

[WireyGinger2877]

Hello Greetings,

I have been working in medical devices from last few years mostly on general quality engineering side. I have taken up a project related Software QA and I am fairly new to it. I am reaching out to folks here at this community so I can get a bit guidance on Software V&V Strategy requirements, maybe a sample document which can help me understand what is required from a Verification Strategy point of view for Medical Device Software Moderate level concern or Class B as per IEC62304.

Thank you for your consideration and I am looking forward for some interesting discussion.

 

[yodon]

That's a fairly lengthy subject to discuss in a forum like this. And recognize that, other than the very basics, a strategy for one company might not be appropriate for your company - which could lead to further confusion.

Have you read the standard (62304) or the FDA Guidance on Software Validation? If not, start there. If so, what specific issues or questions do you have? Specific questions are much easier to deal with. Also, never a bad idea to do some searches here in the Cove for previous, related discussions.