FDA-Aligned Medical Device Penetration Testing Accelerates Time to Market

​Reduce time to market and costs with cybersecurity services designed to assure safety, effectiveness, and regulatory compliance

Traditional penetration testing often create costly delays for medical device companies - generating low-priority, unvalidated, or irrelevant findings that distract from patient safety and clinical effectiveness. Our methodology, developed by former FDA advisors who helped create both premarket and postmarket cybersecurity guidance, focuses exclusively on vulnerabilities that impact device safety and effectiveness.

​

Why Stratigos Security's approach saves time and money:

• Regulatory-first design: Our testing methodology directly maps to regulatory requirements, eliminating surprises and reducing back-and-forth with reviewers

• Safety-focused findings: We prioritize vulnerabilities by patient impact, not theoretical scores - giving your teams clear guidance on what actually needs fixing

• Optimized process: Streamlined reporting and remediation guidance designed for teams moving quickly - and safely - to market

• Proven track record: Used successfully by dozens of medical device manufacturers to achieve FDA approval and clearance without cybersecurity-related delays

​

Our comprehensive approach covers everything from firmware reverse engineering to cloud API testing, vulnerability chaining, and hardware layer evaluation, performed with the rigor regulators expect and the efficiency that helps manufacturers get their life saving technologies in the hands of patients, physicians, surgeons, and care givers who need them.

​

Ready to accelerate your path to market while meeting FDA cybersecurity requirements?

​

Download our detailed methodology to see how we eliminate unnecessary work and regulatory friction.

​

Schedule a consultation to discuss your specific device and timeline—no cost, no obligation.