CPhelan
Starting to get Involved
We have received ISO13485:2016 certification and we are heading towards our FIH human clinical trial. Prior to reaching out to our notified body I just wanted to check with people who might have gone a similar route.
With ISO13485 certification, clinical data and an agreement on device classification is this enough without requiring our QMS to be audited against MDSAP?
With ISO13485 certification, clinical data and an agreement on device classification is this enough without requiring our QMS to be audited against MDSAP?