Is there a strong market out there for ISO13485 certification?

Mark Meer

Trusted Information Resource
#11
For what it's worth:

I had an informal discussion with one of our auditors, and he was lamenting the high turn-over rate of auditors.

After obtaining sufficient experience, many auditors apparently move on to private consulting.

If this is indeed the case, it might be a good sign for you, as there will (presumably) be a steady flow of job-openings as auditors move on from CBs....
 
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Fearghail

#12
I'm a bit puzzled by the replies you got, because I thought the US market would be the same as the EU. Here in the EU the CE certification for medical devices is booming because there are so many newcomers in the industry. And the easiest way to fulfill the CE requirements in a long run is to get ISO13485.

I live in a town of 200.000 people and I can get a full order book for 13485 consultation even locally.
 
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