Demystifying the Notified Body: Navigating Certification with Confidence

This CHTS 2025 side event provides an inside look at working with notified bodies, featuring insights from BSI and TÜV SÜD.

By Health Tech Hub Copenhagen

Date and time

Tuesday, May 6 · 9:15 - 11:15am CEST

Location

Eigtveds Pakhus

25D Strandgade 1401 København Denmark

Agenda

9:00 AM - 9:15 AM

Arrival & Coffee

9:15 AM - 9:20 AM

Introduction by Health Tech Pathways.

Ellen de Bever, HTHC

9:20 AM - 10:05 AM

Demystifying the Notified Body

Ingeborg Knol, BSI

Derek Nagelkerke, BSI

Theresa Larriba Harboe, TÜV SÜD

Maj Kornø, TÜV SÜD

BSI (20 mins) – Learn how BSI, a leading Notified Body, works with startups to navigate the regulatory pathway. They will break down their process and highlight key pre-clinical challenges startups f...

10:05 AM - 10:10 AM

Short break

10:10 AM - 11:10 AM

Meet the expert

We provide 12 x 20 mins timeslots for one on ones with a Notified Body. During the timeslots that you are not meeting a Notified Body, you get the chance to spar with likeminded founders.

11:10 AM - 11:15 AM

Final remarks

About this event

Event lasts 2 hours

Navigating the regulatory landscape can be challenging for health tech startups. This session provides an inside look at working with notified bodies, featuring insights from two Notified bodies: BSI and TÜV SÜD.

In the first half, industry experts will share key lessons on the certification process. The second half offers the opportunity for one-on-one chats with notified body representatives and peer-to-peer discussions with fellow startups.

This is an official side event of Copenhagen Health Tech Summit 2025 (CHTS). You do not need a CHTS ticket to attend this side event, however, we hope you will join the main conference on 6-7 May 2025.

About Copenhagen Health Tech Summit: Learn from health tech’s trailblazers! On 6-7 May 2025, CHTS 2025 is bringing together visionary leaders, hands-on professionals, and pioneering innovators who have not only confronted healthcare’s biggest hurdles but transformed them into real solutions. Join us to discover how they’ve pushed boundaries, learn from their collaborative journeys, and gain the insights to drive meaningful change in healthcare. More information: Copenhagen Health Tech Summit 2025

Organized by

Health Tech Hub Copenhagen

Health Tech Hub Copenhagen brings together actors and partners from all parts of the health tech and healthcare sector. We work towards breaking down barriers and paving the way for innovative health tech solutions, so that they can solve the challenges for which were created.