FDA Cybersecurity

FDA Cybersecurity Testing

The FDA requires manufacturers to demonstrate that medical devices are secure, resilient, and resistant to cyber threats. Our services support every phase of your FDA cybersecurity submission:

1. Security Requirements (Manufacturer)

• Evidence that security requirements identified through threat modeling have been implemented
• Documentation of system boundaries and security assumptions

2. Threat Mitigation (Manufacturer)

• Verification that risk controls are effective under real-world conditions
• Testing of policy enforcement

3. Vulnerability Testing (Manufacturer or Independent Third Party)

• Robustness testing and fuzzing
• Static and dynamic analysis
• Attack surface review
• Closed-box vulnerability scanning
• Software composition analysis of binary executables

4. Penetration Testing (Independent Third Party)

• Identification and exploitation of security vulnerabilities
• Detailed reports covering tester independence, methods, results, and findings

Lightship provides fully independent penetration testing and supports manufacturers through every stage of FDA cybersecurity compliance, from design inputs to regulatory submission.