Cybersecurity Testing > Vulnerability Testing
Don’t Get Surprised
From standalone devices to full system-of-systems architectures, our engagements combine premarket threat analysis, targeted penetration testing, and structured remediation support.
Vulnerability Testing Capabilities
Modern medical systems are complex, connected, and increasingly reliant on third-party components. That complexity introduces risk—often in places you wouldn’t expect. Harbor Labs helps medical device manufacturers identify and remediate cybersecurity vulnerabilities early, ensuring secure designs, informed submissions, and safe clinical deployment.
Premarket Cyber Threat Analysis (CTA)
Structured threat identification aligned with FDA guidance and regulatory expectations.
Penetration Testing
Targeted ethical hacking across application layers, device endpoints, and system interfaces to surface vulnerabilities.
Vulnerability Assessments
Focused evaluation of known and emerging threats across firmware, software, and network components.
Verification & Validation Support
Formal testing of cyber requirements, including protocol development, execution, defect tracking, and test reporting.
Remediation Strategy
Collaborative support identifying mitigation options, validating fixes, and documenting regulatory responses.
Third-Party Risk Assessment
Security evaluation of third-party and peripheral components, including vulnerability scoring and disclosure guidance.
Deeper insights.
Targeted remediation.
Neutralized threats.
Wearable ECG Device
Regulatory support for a wearable ECG device, including cybersecurity documentation, SDLC procedures, formal testing, and tailored eSTAR submission for FDA premarket guidance.
Regulatory Compliance & Submission Support
We generate the regulatory-grade reports you need for submission—including CVSS scoring, penetration testing results, risk analyses, and postmarket documentation—ready for integration into the eSTAR package and other FDA formats.
Looking for something else?
We also help teams with:
Persistent Vunerability Monitoring
Ongoing threat monitoring for postmarket compliance and clinical safety.
Hardware Testing
Hands-on teardown and analysis of physical interfaces and embedded systems.
Software & Firmware Testing
Targeted testing for integrity, behavior, and exploitable weaknesses.
Software Design & Development
Secure system architecture and coding support from day one.