WATCH NOW: Mapping cybersecurity standards to FDA guidance

A set of standards published by UL to address medical device cybersecurity issues will soon be adopted by the US Food and Drug Administration to help manufacturers support security assurance claims. The UL 2900 standards were developed to provide manufacturers with testable and measurable criteria to assess medical device software vulnerabilities and security controls as well as identify security improvements.

In this one-hour webinar, we discuss various aspects of medical device cybersecurity and how the new standards correspond to FDA guidance. This is particularly important for manufacturers preparing to submit new network-connected devices and software via the FDA 510(k) submission process. What you will learn:

  • Overview of ANSI UL 2900-1: General requirements for software cybersecurity for network-connectable devices and products
  • Overview of UL 2900-2-1: Particular requirements for network-connectable healthcare system components including medical devices and software
  • Overview of how the requirements of the UL 2900 standards help manufacturers meet the FDA guidance for pre- and post-market management of cybersecurity

About the presenter:
Laura Élan is the Practice Leader – Digital Health and Cybersecurity at UL and a licensed Professional Engineer. With over 25 years of experience, her expertise includes project management, software design, and software development processes and regulatory performance. Laura holds a Master of Science in Electrical Engineering from the Illinois Institute of Technology.

This webinar was recorded on August 10, 2017.