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

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2022-01-19
- Length: 1h 29m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-19-015-would-you-use-it-on-a-family-member-with-monir-el-azzouzi
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/015---Would-You-Use-it-on-a-Family-Member--with-Monir-El-Azzouzi-e1cck0l

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-19-015-would-you-use-it-on-a-family-member-with-monir-el-azzouzi#t=0) Introduction: Monir El Azzouzi and Easy Medical Device
- [5:12](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-19-015-would-you-use-it-on-a-family-member-with-monir-el-azzouzi#t=312) Blogging Strategy and Content Creation Process
- [13:50](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-19-015-would-you-use-it-on-a-family-member-with-monir-el-azzouzi#t=830) EU MDR vs US FDA QSR and 510k/PMA Pathways
- [23:36](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-19-015-would-you-use-it-on-a-family-member-with-monir-el-azzouzi#t=1416) EU Classification Rules and Pre-Submission Limitations
- [30:07](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-19-015-would-you-use-it-on-a-family-member-with-monir-el-azzouzi#t=1807) MDD to MDR Transition: AI, Software, and Private Labeling
- [44:30](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-19-015-would-you-use-it-on-a-family-member-with-monir-el-azzouzi#t=2670) MDSAP and Harmonization Efforts
- [50:32](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-19-015-would-you-use-it-on-a-family-member-with-monir-el-azzouzi#t=3032) Notified Bodies: Role, Selection, and Audits
- [1:11:06](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-19-015-would-you-use-it-on-a-family-member-with-monir-el-azzouzi#t=4266) Authorized Representatives and Brexit Impact
- [1:17:06](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-19-015-would-you-use-it-on-a-family-member-with-monir-el-azzouzi#t=4626) Quality Mantra and Management Philosophy

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)

## Most relevant to

early-stage companies

## Mentioned

- Easy Medical Device (company)
- Johnson and Johnson (company)
- EU MDR (other)
- FDA (other)
- ISO 13485 (other)
- MDSAP (other)

## Related episodes from other shows

- [How does EU MDR impact your Quality Management System?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-22-how-does-eu-mdr-impact-your-quality-management-system) (Global Medical Device Podcast)
- [Assessing the Global Regulatory Landscape](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-10-21-assessing-the-global-regulatory-landscape) (Global Medical Device Podcast)
- [[LIVE] How EU MDR Changes are Impacting the Medical Device Ecosystem](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-04-22-live-how-eu-mdr-changes-are-impacting-the-medical-device-ecosystem) (Global Medical Device Podcast)
- [Challenges for Regulatory Submission: EU vs. US](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-06-challenges-for-regulatory-submission-eu-vs-us) (Global Medical Device Podcast)
- [Tips to Prepare for EU MDR and IVDR as Deadlines Draw Near](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-17-tips-to-prepare-for-eu-mdr-and-ivdr-as-deadlines-draw-near) (Global Medical Device Podcast)

## Citing this page

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