GOVERNMENT SERVICES
- 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.
COMMERCIAL SERVICES
- 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
- Medical Device, Enterprise and Document Security
- Cybersecurity Training & Virtual CISO Services
- Subject Matter Expert (SME) Certifications – CISSP-ISSAP, ISSMP, Security+ CE, CompTIA A CE, CEH
Topics:
- Medical Device Cybersecurity
- Medical Device Cybersecurity: US Requirements
- Medical Device Cybersecurity: EU Requirements
- FDA Premarket Cybersecurity Submission Expectations
- LP3 Medical Device Cybersecurity Services Offered
