NIST, FDA, and EU Cybersecurity Mandates and Statutes Compliance.
Executive Order (EO) improving the Cybersecurity of the Federal Government (OE 14028) – highlights FDA guidance.
Manufacturers are responsible for remaining vigilant about risks and hazards including risks related to cybersecurity.
Manufacturers are responsible for putting appropriate mitigations in place to address patient safety risks and ensure proper device performance.
The Medical Device Reporting (MDR) regulation (21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA.
Medical Device Architecture Security Experts
Threat Modeling and Security Risk Analysis
Security Experts Participate in Design
Forensics and Incident Response
Cyber Security Penetration and Vulnerability Testing
Post-Market Continuous Monitoring and Reporting
Supply Chain Risk Management / Third Party Risk Management