Validating Medical Device Cybersecurity Through Penetration Testing: What MDIC's New Best Practices Mean for Developers
June 29, 2026
Focus area
Medical device cybersecurity
Premarket cybersecurity documentation for connected devices and SaMD: threat modeling, SBOMs, security risk management and testing evidence.
How we help
Threat modeling
System architecture views and threat models at the level of detail FDA reviewers look for.
SBOM and vulnerabilities
Software bill of materials, vulnerability assessment and support plans for third-party components.
Security risk management
Security risk assessment linked to your safety risk file and design controls.
Testing and postmarket
Penetration testing scope, test reports and postmarket vulnerability management plans.
