Building an Audit-Ready Secure SDLC: Traceability Across Cybersecurity Risks & Vulnerabilities

March 18, 2025, 11:00 am EST • 60 mins

As medical devices become more complex—incorporating AI and increased connectivity—ensuring compliance with FDA and EU MDR requirements is more challenging than ever. Teams responsible for making sure products are safe and effective must manage intricate software supply chains, document SBOMs, and mitigate cybersecurity risks, all while maintaining end-to-end traceability. Without the right processes, compliance gaps can delay product releases and jeopardize patient safety.

What you'll learn

• Create end-to-end traceability across product security risks, requirements, and evidence of control verification
• Stay audit ready to meet FDA and EU MDR requirements and standards like ISO 27001
• Integrate your SBOM and vulnerability management tools into your SDLC for better traceability and risk mitigation

Clips from this Webinar

Speakers

Gabriel Pascualy

Head of Product
Ketryx
Formerly
Principal Investigator, MITRE

David Semko

Director of Client Operations & Head of Implementation
Ketryx
Formerly