Resources
Regulatory knowledge you can use.
Articles, guides, and expert perspective on the regulatory questions in front of you.
Latest
Regulatory Matters
Great Britain will keep accepting CE-marked devices
The UK regulator, the MHRA, confirmed the decision on 21 October, after a consultation that drew more than 1,000 responses. Legislation and a start date are still to come. Also in this issue: register your devices in EUDAMED before 28 November, four FDA cases from October, and eight dates to watch.
Daren Wilson · 22 October 2026
Article
How a Technical File Gets Built: Experts, Rules, VI, and You
A technical file under the Medical Device Regulation (MDR) or the In Vitro Diagnostic Regulation (IVDR) is the argument a Notified Body reads before it decides anything about your device. Venitara builds that file from four parts, and each one has a single job
Niko Mangold · 9 October 2026
Field guide
Base camp: how to write an intended purpose that holds all the way to the summit
A field guide for MedTech founders on the one paragraph that decides your device class, your evidence, and your route to market.
Niko Mangold · 8 October 2026
News
HealthSeed AG and Mangold Consultants introduce Venitara
Developed for medical device, SaMD and in vitro diagnostic companies, Venitara provides professional regulatory approval support in the EU, USA and Gulf region.
15 September 2026
Newest first
Regulatory Matters
Great Britain will keep accepting CE-marked devices
The UK regulator, the MHRA, confirmed the decision on 21 October, after a consultation that drew more than 1,000 responses. Legislation and a start date are still to come. Also in this issue: register your devices in EUDAMED before 28 November, four FDA cases from October, and eight dates to watch.
Daren Wilson · 22 October 2026Article
How a Technical File Gets Built: Experts, Rules, VI, and You
A technical file under the Medical Device Regulation (MDR) or the In Vitro Diagnostic Regulation (IVDR) is the argument a Notified Body reads before it decides anything about your device. Venitara builds that file from four parts, and each one has a single job
Niko Mangold · 9 October 2026Field guide
Base camp: how to write an intended purpose that holds all the way to the summit
A field guide for MedTech founders on the one paragraph that decides your device class, your evidence, and your route to market.
Niko Mangold · 8 October 2026News
HealthSeed AG and Mangold Consultants introduce Venitara
Developed for medical device, SaMD and in vitro diagnostic companies, Venitara provides professional regulatory approval support in the EU, USA and Gulf region.
15 September 2026
News
Venitara launch, questions and answers
How the platform, the expert services and the three levels of assurance work, and what Venitara does not do.
15 September 2026
Article
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
Niko Mangold · Reviewed 9 October 2026
Article
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
Niko Mangold · Reviewed 9 October 2026
Article
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
Niko Mangold · Reviewed 27 July 2026
Article
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
Niko Mangold · Reviewed 27 July 2026
Article
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
Niko Mangold · Reviewed 27 July 2026
Article
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
Niko Mangold · Reviewed 27 July 2026
Article
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
Niko Mangold · Reviewed 27 July 2026
Article
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
Niko Mangold · Reviewed 27 July 2026
Article
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
Niko Mangold · Reviewed 27 July 2026
Guide
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
Niko Mangold · Reviewed 25 July 2026
Guide
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
Niko Mangold · Reviewed 25 July 2026
Article
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
Niko Mangold · Reviewed 21 July 2026
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.
Niko Mangold · Reviewed 21 July 2026
Guide
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
Niko Mangold · Reviewed 21 July 2026
Article
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
Niko Mangold · Reviewed 21 July 2026
Article
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
Niko Mangold · Reviewed 21 July 2026
Article
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
Niko Mangold · Reviewed 21 July 2026
Article
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
Niko Mangold · Reviewed 21 July 2026
Article
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
Niko Mangold · Reviewed 21 July 2026
Article
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
Niko Mangold · Reviewed 21 July 2026
Article
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
Niko Mangold · Reviewed 21 July 2026
Article
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
Niko Mangold · Reviewed 21 July 2026
Article
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
Niko Mangold · Reviewed 21 July 2026
Guide
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
Niko Mangold · Reviewed 2 July 2026
Guide
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
Niko Mangold
Guide
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.
Niko Mangold
Guide
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
Niko Mangold
Guide
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
Niko Mangold