Medical Device: Quality Management System processes

When building, maintaining, or developing a QMS everybody is aware, that there need to be procedures, policies, and work instructions in place. But not that many thinks of them as them as processes. That is too bad, because that is what they really are. And there is time to spare to get them front and …

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EU MDR postponed until 26 May 2021. Relax, plenty of time?

The full implementation of the EU MDR (Medical Device Regulation) was recently postponed until 26-May 2021 and for any Medical Device company that wants to sell their products in the European Marketplace, they have to be compliant with MDR. So, now you have plenty of time to get fully compliant with MDR? Not really, I’m …

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