# #466: Leaving the Ivory Tower - How Notified Body Engagement Unlocks Startup Growth

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2026-07-27
- Length: 31m
- Episode: 466
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-07-27-466-leaving-the-ivory-tower-how-notified-body-engagement-unlocks-startup-growth
- Listen: https://podcast.greenlight.guru/episode/de-risking-medtech-how-early-notified-body-engagement-unlocks-startup-growth

## Summary

Malte Knowles Schmidt, Global Portfolio Lead for Medical Device Software, AI, and Cybersecurity at TÜV SÜD, explains how early-stage medtech startups can demonstrate regulatory maturity to investors before achieving full certification. He advocates for 'leaving the ivory tower' by engaging notified bodies early, implementing an enterprise Quality Management System (eQMS), and pursuing partial ISO 13485 certification for core design processes. Schmidt warns against 'Pyrrhic certifications' where commercial viability is sacrificed for regulatory approval and suggests using external testing as strategic evidence of progress.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-07-27-466-leaving-the-ivory-tower-how-notified-body-engagement-unlocks-startup-growth#t=0) Introduction: The Regulatory Ivory Tower Challenge
- [2:01](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-07-27-466-leaving-the-ivory-tower-how-notified-body-engagement-unlocks-startup-growth#t=121) Bridging the Gap Between Startups and Notified Bodies
- [4:26](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-07-27-466-leaving-the-ivory-tower-how-notified-body-engagement-unlocks-startup-growth#t=266) Defining Regulatory Maturity and the Agile QMS
- [7:03](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-07-27-466-leaving-the-ivory-tower-how-notified-body-engagement-unlocks-startup-growth#t=423) The Value of Partial ISO 13485 Certification
- [11:29](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-07-27-466-leaving-the-ivory-tower-how-notified-body-engagement-unlocks-startup-growth#t=689) Using External Testing as Evidence Breadcrumbs
- [16:12](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-07-27-466-leaving-the-ivory-tower-how-notified-body-engagement-unlocks-startup-growth#t=972) Initiating Contact and Avoiding Pyrrhic Certifications

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Fundraising & investors](https://hardwarepodcasts.com/topic/fundraising)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

early-stage companies

## Mentioned

- TÜV SÜD (company)
- Biotronik (company)
- Greenlight Guru (company)
- ISO 13485 (other)
- FDA (other)
- MDR (other)

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- [216 - How UAE and Singapore Are Redefining Regulatory Innovation with Stephen O'Rourke](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-03-216-how-uae-and-singapore-are-redefining-regulatory-innovation-with-stephen-orou) (Let's Combinate)
- [S6E19 Stuart Grant | MedTech Innovation](https://hardwarepodcasts.com/podcast/being-an-engineer/2025-05-09-s6e19-stuart-grant-medtech-innovation) (Being an Engineer)
- [Etienne Nichols | How to Become a MedTech Engineer](https://hardwarepodcasts.com/podcast/being-an-engineer/2023-03-24-etienne-nichols-how-to-become-a-medtech-engineer) (Being an Engineer)
- [S1E13 A Holistic View on Product Development | Devon Campbell](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-09-s1e13-a-holistic-view-on-product-development-devon-campbell) (Being an Engineer)
- [017 - "Feet First" with Ahmed Zobi](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-26-017-feet-first-with-ahmed-zobi) (Let's Combinate)

## Citing this page

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