Basic

I will list here some of the best tools I had the chance to use or to discover for a Medical Device Quality and Regulatory affairs department

With the new Medical Device Regulation EU MDR 2017/745 the survival of OBL Own Brand Labelling and OEM Original Equipment Manufacturer is under question. I try to explain their situation as some strategy need to be in place for them to be still alive after May 26th, 2020.

The Declaration of Conformity is a pillar on the Medical Device Regulations. So learn what should be included inside and be creative as I have a challenge for you.

On this article I help you to understand what is a Certificate of Free Sale (CFS) or a Free Sale Certificate (FSC). I include links of member states so it is easy for you.

Quelles sont les technologies qui vont devenir tendance pour les dispositifs médicaux? Et quelles sont les réglementations qu’il faut surveiller? Dans ce blog post et cette épisode de Medical Device made Easy Podcast, je vous présente les tendances dans le monde du Dispositifs Médical pour 2019

As this is the beginning of the year, I will try to predict the future of the Medical Device industry. I created this article out of the Medical Device made Easy Podcast. So you can also listen to it.