Webinars
Building an FDA 510(k) Threat Model Report: What Reviewers Expect in 2026 and Beyond
Event Details
A well organized threat model report facilitates the medical device manufacturer to communicate the identification of threats, risk assessment and mitigation through the device system. The documentation for the FDA 510(k) submission should clearly demonstrate a relationship between system architecture, potential attack scenarios, cybersecurity risks and their mitigation.
Medysec will discuss in this webinar how to create a comprehensive FDA 510(k) threat model report that clearly and transparently communicates cybersecurity risks and security controls. Understand how to identify system boundaries, attack surfaces, understand structured approaches to threat modelling and how to link threat scenarios to risk assessments and security evidence.
What You'll Learn
This webinar provides practical insights into developing medical device threat models and preparing cybersecurity documentation in line with FDA premarket submission considerations.
You will learn:
- Understand the role of threat modeling in FDA 510(k) cybersecurity documentation and relevant considerations under Section 524B of the FD&C Act for applicable cyber devices.
- Identify common threat model documentation gaps, including incomplete architecture diagrams, unclear trust boundaries, and insufficient coverage of external interfaces and third-party dependencies.
- Apply structured threat modeling approaches, including STRIDE and attack trees, to identify potential attack scenarios and evaluate cybersecurity risks.
- Establish traceability between system architecture, identified threats, risk assessments, security controls, and supporting verification and validation evidence.
Who Should Attend
- Regulatory Affairs and Quality Assurance professionals involved in FDA 510(k) submissions.
- Medical device cybersecurity engineers, security architects, and product security leaders responsible for threat modeling and risk assessment.
- Medical device founders, CTOs, software development teams, and submission owners preparing cybersecurity documentation for FDA premarket review.
