Medical Device School: How to audit your Suppliers?

Medical Device made Easy Podcast · Jan 8, 2020

A supplier audit is a difficult task that really needs to be well understood. With the new Medical Device Regulation EU MDR 2017/745, there is a specific requirement that Medical Device Manufacturers should have better control of their suppliers.

I always hear that as soon as the supplier is ISO 13485 it is sufficient for the manufacturers, but this is not really answering the question if your product is manufacturers following your specification…

So I propose to more focus on product specification instead of ISO 13485 requirements. Check the discussion I have with Stefan Bolleininger…