IEC 81001-5-1 & Medical Device Cybersecurity

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cybersecurity is a special concern for Many industries, including the medical device industry

Quality healthcare depends on secure access to medical technologies that use software and communication protocols to exchange patient information with other systems and devices. Cyber breaches affecting medical devices put risk patient safety and compromise healthcare quality worldwide.

The International Electrotechnical Commission (IEC) has 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).

In this white paper, our expert discusses the state of medical device cybersecurity and provides details on the scope and requirements of IEC 81001-5-1.

Complete the form to download the white paper.

Download the white paper to learn:

Get an overview of the implementation timeline for the standard and how device manufacturers can integrate the standard’s requirements into their product development activities.

Key Topics Covered:

  • 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 Expert

Dr. Abtin Rad
Global Director Functional Safety, Software and Digitization, TÜV SÜD, Munich Germany

Dr. Abtin Rad has 13 years of professional experience as a Biomedical and Electrical Engineer focusing on Software, Cybersecurity, and Artificial Intelligence. Dr. Abtin Rad is a Cybersecurity and Artificial Intelligence Specialist for medical devices and medical software and a Lead Auditor for ISO 13485, ISO 9001, MDSAP, and MDD/MDR.




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