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

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.

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