Complete, practical answers to a real founder question.
Guides
Pillar guides for medical device and digital health founders. Each guide answers its question end to end, cites its regulatory basis, and carries a last-reviewed date.
P-1
The EU AI Act for Medical Devices: The Complete Founder's Handbook
If you are building AI into anything that touches diagnosis, treatment, monitoring, or prevention of disease, you are almost certainly navigating two regulatory frameworks at once, whether or not you have mapped both yet. The EU AI Act doesn't replace MDR or I
P-2
Is It a Medical Device? The Ultimate Classification Guide (EU + US)
Every health tech founder eventually asks some version of the same question: is this thing I'm building actually a medical device, and if so, how heavily regulated is it. The honest answer is almost never a flat yes or no. It depends on what your product claim
P-3
CE Marking for Medical Device Software: The Full Route
If you are building software that treats, diagnoses, monitors, or otherwise makes clinical decisions easier for a patient or clinician in the EU, CE marking is very likely somewhere on your roadmap, whether or not your team has said that sentence out loud yet.
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FDA Clearance for Health Software: The Complete Guide
Getting a piece of health software through FDA takes a sequence of decisions: whether it is a device at all, which of three pathways fits, how you build a predicate argument (or a direct safety case, if you have no predicate to lean on), what documentation FDA
P-5
One Dossier, Three Markets: The Multi-Market Regulatory Guide (EU → US → MENA)
Most founders planning EU, US, and MENA market entry price it as three separate regulatory projects, because that is how the invoices usually arrive: three technical files, three consultancies, three timelines that don't talk to each other. It doesn't have to
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The Health Tech Founder's Regulatory Playbook: Where to Start, What It Costs, When You'll Launch
Most health tech founders don't fail regulatory strategy because they misunderstand a rule. They fail it because they discover the rules too late to plan around them: a Notified Body queue that's longer than the fundraising runway, a predicate device that does
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Data & AI Governance for Health Tech: GDPR, AI Act Article 10, and What Comes Next
If you are building a health AI product, you are not answering to one regulator. You are answering to three, simultaneously, out of the same underlying system: GDPR governs the personal data your product touches, MDR governs the device your product might be, a
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QMS for Medical Software Startups: ISO 13485 Lean, Serving EU + US (QMSR)
Every founder building a regulated health software product eventually hits the same wall: the quality management system. You don't write it once and file it away. It's the operating system your entire regulatory file runs on, and getting its scope wrong in eit
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