MDR Cybersecurity from a notified bodies perspective

MDR/IVDR Cybersecurity from Notified Bodies Perspective



In the medical device industry, the cybersecurity threat is ever increasing, and malware attacks are believed to endanger patient lives severely. Authorities have agreed to strengthen cybersecurity to counter this, however many standards are not yet harmonized and require some interpretation.

This on-demand webinar provides an insight into TÜV SÜD’s interpretation, as well Team NB’s, on cybersecurity requirements for MDR/IVDR. The expert will also provide more information on State-of-the-Art requirements that are essential to achieve and maintain market authorization. 

Our ON-DEMAND webinar tackle these points, focusing on:

  •  Motivation
  • Regulatory landscape
  • Key messages from MDR & MDCG 2019-16
  • Latest Cybersecurity standards
  • Tips for Technical Documentation submission & audits
  • Common pitfalls of Technical Documentation submissions
  • Q&A (15 mins)

About the speaker

Jan Küfner

Senior Product Specialist, TÜV SÜD

Jan is part of the Medical Healthcare Service Department (MHS) of TÜV SÜD. In his role as Senior Product Specialist (SPS) he is responsible for defining minimum requirements for MDR / IVDR market authorization (according to laws and guidance) and creating templates for MDR/IVDR premarket authorization and MDR/IVDR audits.

He also works on developing Unannounced Audit Pen-Testing testing, creating and conducting training, and actively conducts penetration tests, as well as premarket authorization assessments and audits.

Jan is also a member of the 60601-4-5 standardization committee.

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