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Medical Device Cybersecurity Guide

As medical devices become more connected, there is the potential to impact patient safety. This is evident as cybersecurity incidents have rendered medical devices and hospital networks inoperable, disrupting the delivery of patient care across healthcare facilities worldwide. The purpose of this Work Item is to promote a globally harmonized approach to medical device cybersecurity that at a fundamental level ensures the safety and performance of medical devices while encouraging innovation. The Work Item is thus intended to provide medical device cybersecurity guidance for stakeholders across the device lifecycle.

The working group will develop an IMDRF Technical Document that will provide guidance that includes but is not limited to medical device cybersecurity definitions, stakeholders' shared responsibility, and information sharing.

  • Medical Device Cybersecurity Guide

Working Group Chair: Suzanne Schwartz, US FDA and Marc Lamoureux, Health Canada

Working Group Membership: Regulator and stakeholder membership (membership to be advised)