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MDSAP scope vs ISO 13485 Scope

K

krism

#1
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.
 
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Edward Reesor

Trusted Information Resource
#2
When doing MDSAP certification, you declare where you want to sell your product as there are different aspects and definitions to the different sections of the program. For example, we do not sell in Japan, Brazil or Australia, so the audit was focused only on the US and Canada. I asked about selling in another area once we were certified and I was informed that we have to get that jurisdiction's portion of MDSAP approved before we start selling there (of course, each new jurisdiction has an associated cost, so the greater the areas you sell in, the higher the cost of the audit).

We also upgraded to 13485:2016 at the same time as MDSAP and I didn't see a different in scope, but the more specific you can be for the auditors, the easier it will be for them. They are extremely busy trying to deal with the MDSAP format as well as companies trying to deal with MDSAP so it can be a frustrating mess at the beginning. The message I heard over and over is, "Don't over complicate things, keep your writing simple and organized and keep your auditor happy".
 
K

krism

#3
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.
 

XRAY_3121

Wholesale Distributor Compliance and Regulatory
#4
Do SDS (MSDS) fall under the scope of the MDSAP audit? I need to update ours but getting ready for MDSAP audit and hoping I could put that off until after?
 

Edward Reesor

Trusted Information Resource
#5
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.

I'm sorry I didn't see this message until now. We have a single cert that lists both MDSAP for Canada and USA as well as ISO 3485:2016. Now that I look back at the discussion thread, your question was in October and we received our certification at the end of December.
 
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