primavesvera
Involved In Discussions
Greetings!
I am fairly new to this forum and I have searched through related topics, but I still haven't found my answer, so I'd appreciate if somebody could help me.
What am I dealing with: we have a FDA cleared device and the idea is to submit the new version of the device for Special 510k. I have slight confusion due to the fact that I (my position is within quality management area )need to prepare a document related to the design controls, but my boss doesn’t want to do verification and validation, since he thinks that validation is the pathway for Traditional 510k.
So, my question is – for the summary of design controls in the case of Special 510k, do we need to do both verification and validation of our new device compared to the predicate or we need to do only verification?
Thanks in the advance.
I am fairly new to this forum and I have searched through related topics, but I still haven't found my answer, so I'd appreciate if somebody could help me.
What am I dealing with: we have a FDA cleared device and the idea is to submit the new version of the device for Special 510k. I have slight confusion due to the fact that I (my position is within quality management area )need to prepare a document related to the design controls, but my boss doesn’t want to do verification and validation, since he thinks that validation is the pathway for Traditional 510k.
So, my question is – for the summary of design controls in the case of Special 510k, do we need to do both verification and validation of our new device compared to the predicate or we need to do only verification?
Thanks in the advance.