Monir El Azzouzi is the founder of Easy Medical Device, a regulatory affairs consulting company with a focus on educating and training professionals in the medtech industry. We had a great conversation about the profession, the need for a regulatory framework, the new EU Medical Device Regulation and what it takes to be a consulting business.
Links:
Easy Medical Device - [ Ссылка ]
Social Platforms
Spotify - [ Ссылка ]
Timestamps
0:00 - Introduction
3:00 - Easy Medical Device journey
10:10 - The future of the RA profession
16:20 - Why we regulate device and a history of regulatory systems
20:09 - The Medical Device Regulation (EU)
25:57 - 5 things you need to get into the EU market
27:49 - Biggest stumbling block for getting into the EU market
34:17 - The PIP adverse event
37:55 - The future of regulation in Europe
41:10 - A rebuttal against the MDR in Europe
47:56 - What Easy Medical Device does
