Plain-language reads on the regulation that actually shapes your roadmap.
Articles
Short pieces on classification, technical files, clinical evidence, and the building blocks first-time founders keep discovering six months too late.
Guide
EU AI Act for Medical Devices: What Founders Need to Know
If you're building AI into a product that is already, or might become, a regulated medical device, the AI Act isn't a separate compliance project. It's a second layer on top of work you're already doing under MDR, and [the EU AI Act for medical devices](/resou
Guide
Is My Software a Medical Device? MDR Rule 11 Explained
Founders building health software usually ask this question the wrong way round: "is this a medical device?" as if it were a binary yes or no about the product itself. Under EU MDR, the answer turns on purpose, not technology, which is the same test at the cen
Article
Is My Health AI a Medical Device? FDA Clearance Explained
"Do I need FDA clearance?" is one of the most common questions a health AI founder asks, and one of the most consistently under-answered, because the honest answer depends on exactly what your software claims to do, not on how clinical it feels to build.
Guide
AI Act + MDR: How Dual Conformity Assessment Works
A device that is both a regulated medical device and a high-risk AI system does not go through two separate approval processes run by two separate bodies. It goes through one Notified Body, working from one technical file, checking against two sets of requirem
Policy summary
AI Act Deadlines for Medical Devices: Current Status
This is the page in our content set we update most often, on purpose, and it carries the current dates for the obligations set out in [the EU AI Act founder's handbook](/resources/guides/eu-ai-act-medical-devices-handbook). AI Act timing for medical devices ha
Guide
High-Risk AI Classification in Healthcare, Explained
Founders often ask "is my AI high-risk?" as though there were one test to run. In healthcare there are two separate routes into high-risk status under the EU AI Act, and they work differently enough that conflating them leads to real misclassification. Both ro
Thought
Agentic AI Governance in Healthcare: An Honest Map
No regulator has published a framework written specifically for agentic AI in healthcare. That isn't a gap we can fill for you with a confident answer, and we're not going to pretend otherwise. What does apply is the existing obligation set, and [health data a
Guide
Medical Device Classification Under EU MDR (I–III)
Every decision that follows from here, your evidence requirements, your timeline, your budget, your route to market, is downstream of one determination: which class your device falls into. This guide walks through how that determination is made under MDR, and
Guide
Where to Launch First: EU, UK, or US? A Founder's Guide
Founders usually ask this question as if it were about ambition: which market matters most to us. It is actually a question about your device class in each system, and the answer to that question can point you somewhere your ambition wouldn't have picked. It i
Guide
CE Marking Cost and Timeline for Medical Software
The honest answer to "how much does CE marking cost" is a range, and the range is wide enough that quoting a single number would mislead more founders than it helped. This guide breaks down what actually drives the cost and the time, so you can budget against
Pillar guide
One Dossier, Three Markets: CE to FDA to SFDA Reuse
Building three separate regulatory submissions from scratch for three markets is the default assumption for most founders, and it is more expensive than it needs to be. The method that avoids it is [reusing your CE technical file for FDA and SFDA](/resources/g
Guide
Wellness App or Medical Device? Where FDA Draws the Line
Every health app founder eventually asks whether they need FDA clearance, and most of them are actually asking the wrong question. The real question is narrower and more answerable: does your product make a claim that crosses FDA's general wellness line. The E
Guide
CE Mark vs FDA Clearance: The Real Differences, Side by Side
"Does my FDA clearance help me in Europe?" is one of the most common questions we hear from US-first founders, and the answer, no, surprises almost everyone the first time they hear it clearly stated. Rather than re-explaining each fact about CE marking or FDA
Guide
How Long a 510(k) Really Takes (and Why Most Hit at Least One Round of Questions)
Founders planning around FDA's stated 90-day review clock are planning around a number that rarely reflects reality, and the preparation that moves it is set out in [FDA clearance for health software](/resources/guides/fda-clearance-health-software-guide). Thi
Guide
510(k) vs De Novo vs PMA: Choosing Your FDA Pathway
Once you know your product is a medical device under FDA's definition, the next decision, which of three pathways to pursue, shapes your timeline, your cost, and the specific evidence you need to build. This guide sets out how the choice is actually made, incl
Guide
Building an MDR Technical File and CER from Scratch
Most teams facing a blank technical file underestimate how structured the task actually is. MDR tells you almost exactly what belongs in the file and in what order. The hard part isn't figuring out the structure, it's generating the evidence each section deman
Guide
FDA PCCP: Updating AI Medical Devices Post-Clearance
AI models improve with more data and retraining, but a cleared medical device's behaviour is supposed to be fixed at the point of clearance. FDA's predetermined change control plan is the mechanism that reconciles these two facts, and it's worth understanding
Guide
PRRC Under MDR Article 15: What Small Teams Must Know
Of all the roles MDR requires, the PRRC is the one small teams most often treat as a box-ticking formality, right up until a Notified Body audit reveals it is nothing of the sort. This guide sets out what the role actually requires, where early-stage teams typ
Policy summary
QMSR 2026: FDA's Quality System Change, Explained
If you're building toward a US medical device submission and your quality management system planning still references FDA's old Quality System Regulation by name, you're working from a superseded framework. This page sets out what actually changed in February
Guide
SFDA Medical Device Registration (MDMA) Guide
Saudi Arabia's SFDA is often treated as an afterthought behind EU and US market entry, and that's usually a sequencing mistake rather than a reflection of the market's real size or the registration's real difficulty relative to a CE or FDA submission. This gui
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