Hardware Podcasts

015 - "Would You Use it on a Family Member?" with Monir El Azzouzi

Let's Combinate · 19 Jan 2022 · 1h 29m

What this episode covers

Monir El Azzouzi of Easy Medical Device explains the transition from the EU Medical Device Directive (MDD) to the Medical Device Regulation (MDR), highlighting the shift from self-certification to notified body oversight and the impact on private labeling. He details the structural differences between US FDA pathways (510k, PMA) and EU classification rules, noting that MDR requires full technical files for brand owners rather than just distributors. El Azzouzi also discusses the role of notified bodies, the conflict of interest preventing them from offering pre-submission guidance, and the importance of the 'would you use it on your family?' mantra in quality assurance.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Easy Medical Device, Johnson and Johnson
Also
EU MDR, FDA, ISO 13485, MDSAP

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