MDSAP and ISO 13485

chris1price

Trusted Information Resource
#1
If a company is certified to MDSAP, do they get two certificates one for ISO13485 and one for MDSAP, or does the MDSAP certificate cover both?
 
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shimonv

Trusted Information Resource
#2
MDSAP and ISO 13485 are two separate certificates (one has a broader scope).
I have seen companies that holds two separate separate certificate. You need to ask (and pay) for it.
 

mihzago

Trusted Information Resource
#4
I never understood the reason to maintain and pay for two certificates even though both are based on ISO13485. I'm pretty sure the scope and requirements are the same, MDSAP audit simply asks more questions.

I guess it's just another way CBs can exploit cert holders.
 

LUFAN

Involved In Discussions
#5
I never understood the reason to maintain and pay for two certificates even though both are based on ISO13485. I'm pretty sure the scope and requirements are the same, MDSAP audit simply asks more questions.

I guess it's just another way CBs can exploit cert holders.
It's Auditing Organization specific in my experience. Intertek for example issues 1, UL issues 2 (1 MDSAP / 1 13485). No price difference.

MDSAP is an audit model that incorporates country specific requirements on top of 13485. It does not introduce new requirements.
 

Edward Reesor

Trusted Information Resource
#6
Its two separate things but we have one audit, and the resulting certificate (by Intertek) is one document that lists 13485:2016 as well as MDSAP (listing which countries have been successfully audited since MDSAP covers 5 countries). So our certificate has one line that lists 13485:2016 and below it has MDSAP (Canada and USA).
 
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