Service provider for Medical Devices Repair & Service

[Philipp]

Hi @ all,

I hope anyone of you can help me.

Does anyone of you know if there is a requirement in any country / regulation that service provider who perform repair and service activities in the market for active MD need a certification according ISO 13485?

Thank you

Philipp

 

[shimonv]

Hi Philipp,
I've done regulatory affairs in several global markets and have not seen a regulation requiring that a third party be certified to ISO 13485.

However, most manufacturers and device owners would feel more comfortable if the service provider is certified to ISO 13485 and sometimes may even require it. It's kind of an industry practice..

Cheers,
Shimon