Events
Event
Webinar
FDA
Cybersecurity
US FDA Cybersecurity: 2024 Updates
Understand the latest FDA cybersecurity guidance and what it means for your submission.
10 Apr 2024
45 mins
Dr. Jane Smith
About this Webinar
Cybersecurity is no longer an afterthought; it is a critical component of medical device safety. In this webinar, we break down the FDA's latest final guidance on "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions."
What You Will Learn
- The difference between the 2018 draft and the 2023 final guidance.
- How to structure your Threat Modeling documentation.
- The new requirements for the Software Bill of Materials (SBOM).
- Tips for fielding cybersecurity-related deficiency letters.
Speaker
Dr. Jane Smith, Principal Consultant at Leanabl, has over 15 years of experience in medical device software safety and has successfully cleared over 50 SaMD products.