ISO 13485 certificate needed if I go for MDSAP certification?

QuickSpace

Starting to get Involved
#1
Hi All,

Just curious about this query, Maybe it sounds silly. Just wanted to know if we have to get ISO 13485 certificate if I have MDSAP certification.
 
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GStough

Leader
Super Moderator
#2
That could depend. Do your customers require it? Some customers do require an ISO certificate. Do you sell into countries other than the five that are included in the MDSAP scheme? MDSAP certificates may not hold value in those countries, whereas an ISO 13485 certificate would. Would your company receive any value for obtaining a 13485 certificate?
 

ChrisM

Quite Involved in Discussions
#4
^
What DannyK said, MDSAP "automatically" means ISO13485 and more......

Just to clarify, you don't need to already hold ISO13485 registration, if you go from zero to MDSAP, this includes gaining ISO13485 registration as part of the MDSAP assessment
 
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