Hardware Podcasts

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

Global Medical Device Podcast · 27 Jul 2026 · 31m · Episode 466

What this episode covers

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.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
TÜV SÜD, Biotronik, Greenlight Guru
Also
ISO 13485, FDA, MDR

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