Hardware Podcasts

How does EU MDR impact your Quality Management System?

Global Medical Device Podcast · 22 Feb 2021 · 36m · Episode 181

What this episode covers

Monir El Azzouzi, founder and CEO of Easy Medical Device, explains how the EU MDR impacts quality management systems (QMS) for medical device manufacturers. He details the specific procedural changes required by Article 10.9, the critical differences between ISO 13485 and EU MDR, and the necessity of proactive post-market surveillance. El Azzouzi also warns against relying on unaccredited certification bodies and discusses the logistical challenges of notified body audits during the pandemic.

Most relevant to

companies scaling up

Topics

Mentioned

Companies
Easy Medical Device, Greenlight Guru
Also
ISO 13485, EU MDR, FDA QSR, ISO 9001

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