Your code is ready.
Your technical file isn’t — yet.
From first commit to CE marking, a single point of contact — technical audit, architecture, regulatory strategy, quality file. A former CTO who has led 10+ CE markings and 2 FDA clearances, not just read the standards.
Find the support built for your stage.
From first prototype to post-market surveillance, I support SaMD teams at every step — so no team faces the standards alone.
Building your first device? Lay the regulatory foundations now — without sacrificing product speed.
Already CE-marked? Absorb change without friction: new features, re-submissions, post-market surveillance.
Your device is going connected? Get the software and cybersecurity audited by someone fluent in both hardware and code.
Investing in medtech? An independent, quantified assessment of technical and regulatory risk — before you sign.
The regulatory system is saturated — and your roadmap is paying for it.
Overloaded notified bodies, stacking cybersecurity requirements, documentation discovered at the last minute: every month of waiting costs you market share.
Track your compliance, sprint after sprint.
Tell me about your product
It starts with a 30-minute call: your device, its class, your stage, your deadlines. Free, jargon-free — and you leave with answers.
The audit, in one week
Code, architecture, security and your existing file put under the microscope. You get a prioritised risk map — not an 80-page PDF nobody will read.
An action plan, then execution
A 90-day roadmap built into your sprints: 62304 documentation, risk management and cybersecurity move with the product. I stay until the certificate.
Three offers. A clear scope.
Know where you stand
custom quoteTechnical, cyber and regulatory diagnosis in 5 days. You leave with a prioritised risk map and a live debrief with your team.
Start the auditStructure the trajectory
custom quoteI join your team to build compliance into your sprints — method and scope tailored to your device, all the way to submission.
Discuss a scopeSteady the ship
custom quoteA senior sparring partner, 4–8 days a month: committees, hiring, mentoring — all the way to the certificate.
Request a quoteClassify your device in 2 minutes.
Three questions, an indicative class under MDR Rule 11 — and what it means for your roadmap. No email, no strings attached.
Still have a question?
Book a meetingFive days: code and architecture review, cybersecurity analysis, and a read-through of your existing regulatory file. You receive a prioritised risk map, a criticality matrix and a proposed 90-day roadmap, presented in a 90-minute session with your team.
Ideally before writing the documentation: the earlier the product is structured for compliance, the less it costs. But half of my engagements are rescues — a rejected file or a failed audit can be recovered too.
Yes. Classification strategy, software documentation (62304, §524B cybersecurity) and submission preparation. For direct exchanges with the FDA, I work with a US regulatory partner.
No — I complement them. Your QA/RA knows the standard; I know the code. Notified bodies increasingly probe the technical reality behind the documentation — that is where I come in.
Yes, most engagements are remote, anywhere in Europe, with on-site sessions at key moments (kick-off, final debrief, mock audit). Based in Annecy, France.