K
krism
Does anyone know or had any experience of having the scope in the MDSAP cert differ from what is on the 13485? Is this possible? For my company, we have certain medical devices that we do not want to sell in Canada, but we do in the US.
Thanks Edward. I appreciate your insight. For my situation, my company is small and we are sensitive to costs. We will most likely have our 13485 upgrade audit and our MDSAP audit conducted separately due to our current level of preparedness. In regards to cost, we would like to limit the number of hours needed for the MDSAP audit by narrowing down what we would need to be under the scope, which in our case we hold two medical device licenses in Canada while in the U.S. we have device listings for more products that we do not wish to send to Canada. So my question remains. Would we be able to have a scope on our MDSAP cert that shows something different than what is on the 13485:2016 cert?
Edward, one thing that may lead me to believe (although this won't be conclusive) that it can be separate is if you let me know if you have two separate certs vs. one cert that lists both MDSAP and 13485.