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.
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.