I’ve been building in tech, cyber, privacy, and clinical data for 25+ years across Israeli medical device startups, Verily, Amgen, and the Fortune 1 company. I work at the intersection of engineering, regulatory risk and clinical data — helping teams produce cost-effective, prioritized security countermeasure plans.

I help you turn cyber and privacy risk into clean, defensible, FDA-ready documentation.

Most companies treat cybersecurity as paperwork instead of a logical system.

This is the #1 anti-pattern behind failed FDA submissions. My practical threat analysis system eliminates that anti-pattern. I help teams produce cybersecurity packages that are clear, logically complete, traceable, and aligned with the 2025 FDA Cybersecurity Guidance and Section 524B.

I am the Cyber & Privacy Advisor for WHO Europe. I work across global digital health, safety, and regulatory risk — experience that directly informs my structured, outcome-focused approach.

What I Deliver

• FDA-aligned threat modeling
• Cyber risk analysis with clear logic
• Mitigation & countermeasure plans
• SBOM review + vulnerability-management strategy
• Submission-ready cybersecurity documentation
• Traceability (threat → risk → mitigation → residual risk)
• Training so your team can “run with the ball”
• Fixed-price engagements with no surprises

You don't pay for hours — you pay for a complete, defensible package.

Who I Work With

• Medical-device manufacturers
• Digital health companies
• Digital therapeutics companies
• AI-diagnostic teams
• Healthtech companies
• RA/QA preparing premarket submissions
• CTOs preparing for regulatory scrutiny
• CEOs who want predictable, low-friction compliance

Why Teams Choose Me

• Clear, regulator-ready outputs
• Outcome-based fixed pricing
• System-level thinking instead of checklist thinking
• A method that eliminates reasoning anti-patterns

If you need a clean, defensible cybersecurity package and a cost-effective, prioritized security countermeasure plan —