Cybersecurity in Medical Devices and the role of IEC 81001-5-1

Cybersecurity in Medical Devices and the Role of IEC 81001-5-1

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The number of connected medical devices and the development of digital healthcare applications are growing rapidly. Medical device manufacturers must be aware of cybersecurity to protect patient data and safety.

To help address the growing challenges of software-related cybersecurity concerns linked to medical devices, the International Electrotechnical Commission (IEC) has recently published IEC 81001-5-1, “Health software and health IT system safety, effectiveness, and security—Part 5-1: Security—Activities in the product life cycle.” The standard is expected to gain Harmonized Standard status under the European Union’s (EU) Medical Device Regulation (2017/745, MDR) and is now seen as mandatory by notified bodies.

In this webinar, our expert covers MDR Cyber Security Risk Management and provide details on implementing IEC 81001-5-1 and 60601-4-5.

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Key Topics covered in the webinar:

  • Importance of cybersecurity protection of medical devices
  • Cybersecurity risks associated with medical devices
  • The current state of cybersecurity requirements for medical devices
  • The role of IEC 81001-5-1 in strengthening cybersecurity
  • How TÜV SÜD is working with the medical device industry to address cybersecurity threats 

About the speaker


Senior Product Specialist for Cybersecurity of Medical Devices, Product Specialist, Lead Auditor TÜV SÜD

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