The digitalization of the medical industry and medical devices creates countless opportunities for improving patient care. The requirement: Cybersecurity must be guaranteed so that medical devices are not vulnerable to hacker attacks or pose other risks. Cybersecurity includes the medical devices themselves, but also their interfaces to other products or databases (e.g. in hospitals) as well as companies and their IT infrastructures.

In BVMed’s online seminar, the speakers Miriam Schulze (CEO BAYOOMED), Sebastian Wittor (Project Manager BAYOOMED) and Jan Küfner (TÜV SÜD Product Service) provide insights regarding the cyber security of medical devices. They put the topic in the context of certification and placement on the EU market.

The speakers and cybersecurity experts from BAYOOMED:

Miriam Schulze

Sebastian Wittor
Project Manager

These contents and issues are covered in the online seminar “Cybersecurity for medical devices”:

  • What requirements does the MDR impose on the cybersecurity of medical devices?
  • Which standards, guidelines, directives and other aids are recommended?
  • Expectations and procedures of a Notified Body when reviewing technical documentation with regard to cyber security?
  • Typical questions in a medical device cybersecurity audit?
  • Anchoring the cybersecurity of medical devices in a company’s management systems.
  • Practical experience when a medical device exchanges data with other medical devices or databases.
  • Prospects: What legal requirements can manufacturers and operators of medical devices expect in the coming years and what are the fundamental differences between European legislation and that of the USA?