Online-Event

Healthtech Innovation Insight: FDA & Co. - A compass for international MedTech manufacturers through the regulatory jungle

11. March 2026

15:30 - 16:30

Online-Event

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The global market for connected medical devices is growing, and with it the requirements for cybersecurity. Manufacturers who want to market internationally are faced with different regulatory requirements that must be met for market approval.

The global market for connected medical devices is growing and with it the requirements for cybersecurity. Manufacturers who want to market internationally are faced with different regulatory requirements that must be met for market approval.
In this presentation, you will receive a structured overview of the regulatory landscape in the most important markets and learn about the key differences.
With a focus on the MDR (Medical Device Regulation) relevant for Europe, we provide guidelines on how teams can be sensitized to the topic of cybersecurity, which approach has proven itself in practice and how compliance can be implemented efficiently.

Martin Margraf heads the team for cybersecurity in medical devices at softgate GmbH. He has been developing software in the field of medical devices for 15 years, with a focus on cybersecurity for almost 10 years.

Register now!

You can find all other Healthtech Innovation Insights here.

15:30 - 15:35

Welcome and introduction

Porträt von Lara Kronester
Lara Kronester
+49 911 20671-242
Innovation network Health, Project manager Digital Health, Bayern Innovativ GmbH, Nuremberg

15:35 - 16:15

"MDR, FDA & Co. - A compass for international MedTech manufacturers through the regulatory jungle"

16:15 - 16:30

Q&A

Cooperation partner

Specialist contact person

Porträt von Lara Kronester
Lara Kronester
+49 911 20671-242
Innovation network Health, Project manager Digital Health, Bayern Innovativ GmbH, Nuremberg

Organizational contact person

Anna Gschwilm
+49 911 20671-368
Innovation network Health, Project organisation, Bayern Innovativ GmbH, Nuremberg
Tina Schaffer
+49 911 20671-296
Innovation network Health, Project organisation, Bayern Innovativ GmbH, Nuremberg