FDA cybersecurity compliance for medical device manufacturers and digital health companies.
Five-stage methodology refined over 500+ engagements. Every step designed for efficiency, transparency, and results.
Understand Your Reality
We start with deep discovery—not a sales pitch. Comprehensive assessment of your current security posture, compliance gaps, and business objectives. No assumptions, just evidence.
Architect Your Solution
Custom roadmap built for your specific needs—not a cookie-cutter template. We design security programs that fit your business, budget, and timeline. Zero vendor influence.
Build & Strengthen
Hands-on implementation of policies, controls, and technical safeguards. We do the heavy lifting—documentation, configuration, training—so your team can focus on business.
Test & Verify
Rigorous internal audits and penetration testing before external assessment. We find the gaps before auditors do. Mock audits, remediation, and continuous improvement.
Achieve & Maintain
Guided through certification with 100% first-time pass rate. Post-certification support ensures you stay compliant. Continuous monitoring, not annual panic.
Understand Your Reality
We start with deep discovery—not a sales pitch. Comprehensive assessment of your current security posture, compliance gaps, and business objectives. No assumptions, just evidence.
Architect Your Solution
Build & Strengthen
Test & Verify
Achieve & Maintain
Ready to start your compliance journey?
FDA premarket cybersecurity documentation meeting latest guidance
NIST CSF alignment for medical device lifecycle security
Faster regulatory approval with comprehensive security evidence
Ongoing post-market surveillance and vulnerability management
Reduced FDA audit risk with proactive compliance
Product security by design from initial development
Schedule a consultation to discuss how this solution can help your organization achieve compliance.