US FDA Cybersecurity: 2024 Updates

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.