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 shorter sales cycles and higher prices..
Most companies treat cyber and privacy risk as paperwork instead of a quantitative 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 based on quantitative models
- Prioritized, cost-effective 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, no surprises
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 to know how much money is on the table.
Why Teams Choose Me
- Clear, regulator-ready outputs
- Outcome-based fixed pricing
- System-level thinking
- Quantitative models of your device business instead of regulatory checklists
If you want to reduce deal friction or raise your prices, grab a slot below. —
Book a 15' intro call.