A boutique advisory firm led by operators who have taken companies through FDA, enterprise security reviews and exits.
A boutique advisory firm led by operators who have taken companies through FDA, enterprise security reviews and exits.
Regulation, security and go-to-market, planned as one path to market.
Strategy, go-to-market and security, from people who know how enterprises buy.
You need a pathway, a claim and a Pre-Submission you can stand behind. We build them with you.
A hospital or enterprise deal is waiting on your answers. We get you through the review and fix what it exposes.
Investors will ask about the regulatory path, the security posture and the go-to-market plan. Have one answer for all three.
First customers, first distributors, first contracts. We have taken products into the US before and know what it takes.
Something broke, or a customer found a gap. We help you respond, repair and show buyers it is handled.
An acquirer will open every file. We prepare the regulatory, quality and security story before they ask.
years of combined senior experience
FDA 510(k) submissions
exits to global strategics
regions served: Israel, US, UK, Latin America
installations of products we led, across the US and Europe
enterprise security experience, up to Fortune 10 companies
A B2B software startup kept stalling in the security reviews of global software companies. We reworked its product security strategy, added controls and shipped new security features. The reviews passed and the deals moved.
For a cybersecurity startup entering the United States: a focused go-to-market plan, competitor research, a pricing model, talks with prospective partners and a strategy for working with them.
A medical device company needed a regulatory path and a company strategy that fit together. We set both, led the FDA work, and the submission went through first time.
Ahead of a funding round, we helped a technology company build a new line of business on its existing product, giving investors a bigger company to value.
We have led medical device companies from first prototype through clinical validation and worldwide launch.
More than a dozen 510(k) submissions, plus the cybersecurity work that took an AI-based medical product through FDA's requirements.
Two companies sold to global strategics. We know what an investor and an acquirer look for.
Security, incident response and AI-security work for Fortune 500 and Fortune 10 companies. Today we bring it to startups in medical AI, data infrastructure and offensive security.
More than a dozen 510(k) submissions and PMA experience. We know what FDA asks for, in what order, and what it costs to get wrong.
Years of securing software products and large enterprises, including Fortune 500 companies: architecture, cloud, AI and incident response.
FDA cybersecurity requirements, SOC 2, HIPAA and the quality system behind them, translated into what your team needs to build.
Decades of relationships across MedTech, healthcare and enterprise security, opened for the companies we work with.
We work the way operators do: decide, write it down, get it done. You get a plan your team can run, not a slide deck.
Strategy, regulation, quality, security and go-to-market from the same senior people, so nothing falls between advisers.
We have founded and led technology companies from the first prototype to acquisition. We have sat in your chair.
Ph.D.-level leadership, and three decades of leading medical device companies through development, FDA clearance and market.
Computer science backgrounds, and years of product and enterprise security for some of the world's largest companies.
We have led incident response teams in the military and for global enterprises, from breach to recovery.
We have taken products and services to hospitals and enterprises across Israel, the US, Europe and Latin America.
US subsidiaries, global distributors and cross-border acquisitions. Our work has always crossed borders.
Thirty minutes, and an honest answer on whether we can help.
Two to three weeks, ending with a plan your board can act on.
A few days a month, as your acting regulatory lead, security lead or strategic adviser.
Senior people only. No juniors, no hand-offs, no slide factories. We take on few companies, so each one gets our full attention.
Tell us what is on your table. Thirty minutes, and an honest answer on whether we can help.
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Ra'anana, Israel
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