Fabola helps founders and product teams turn medical device, IVD and AI regulation into a clear, workable plan.
We are based in Sweden and deeply rooted in the European regulatory system, with experience and networks that extend into the United States and China.
Not even sure whether what you’re building is a medical device? That is a perfectly good place to start.
We help you understand:
You do not need to know whether your product falls under MDR, IVDR, the EU AI Act, FDA regulation, NMPA requirements or none of them before speaking to us. Working that out is often the first job.
If your product uses AI, blood tests, biomarkers, genetic data, clinical information, symptoms or other health data, relatively small differences in what the product does and what you claim it does can change the regulatory pathway considerably.
Fabola helps founders answer questions such as:
You do not need to know which regulatory service you need.
Tell us the decision you are trying to make.
Before building your company around the wrong regulatory assumptions, establish the pathway.
We work with:
More validation is not automatically better validation.
Fabola translates intended purpose, claims, technology and risk into an evidence strategy: what needs to be demonstrated, with what data, and to what level of confidence.
Explore AI and validationWe work with:
Conformity assessment should not be the first time you discover what is missing.
Fabola helps companies prepare for European market access while keeping future international expansion in view.
Talk to FabolaWe work with:
A model performing well is not the same thing as a medical device being adequately validated.
For an AI-enabled medical device, the technical, clinical and regulatory parts of the company need to connect.
Fabola works with founders, clinical teams and AI engineers on questions such as:
Fabola’s regulatory home is Europe. We work deeply with the MDR, IVDR, medical device software, CE marking, Notified Bodies and the emerging regulatory environment for AI.
But health technology companies rarely stop at one market. Fabola also works across the regulatory and innovation environments of the United States and China, within a broader international MedTech ecosystem spanning founders, researchers, regulatory professionals, Notified Bodies, innovation environments and market-access networks.
That perspective helps us understand not only what the regulations say, but how products move through real regulatory systems.
That means asking international questions early enough to matter:
Can a validation study support more than one market? Will an EU product claim create problems for a later FDA pathway? Are we collecting the data we will eventually need? Should the US, Europe or China come first? Which parts genuinely need to be market-specific?
The aim is to avoid early decisions that unnecessarily close future options, without creating three regulatory programmes on day one.
Early-stage companies need to know what a regulatory decision will cost, what they will receive and what they will be able to decide afterwards. That is why Fabola works modularly.
Most engagements begin with a defined decision.
Before the work begins, we agree:
No assumption that a first question needs to become a twelve-month consultancy project.
How can Fabola help?Fabola works with founders in ordinary product language first, then translates the regulatory consequences.
Ingela Mauritzon Founder, Fabola
Ingela Mauritzon is a medical-device regulatory specialist and researcher working at the intersection of regulation, artificial intelligence and innovation.
She advises medical device, IVD and health-software companies on regulatory strategy, clinical and performance evidence, AI-enabled products, conformity assessment and international market access.
Her doctoral research at Halmstad University examines AI and regulatory governance in the European medical-device system, including how Notified Bodies respond to technological and regulatory change.
Her work combines regulatory practice with research into how regulation operates around innovative and emerging technologies.
Not automatically.
The answer depends on what the software is intended to do with the information, what output it produces and the medical purpose of that output.
Software using laboratory data can potentially fall under IVDR, MDR or outside medical-device regulation depending on its intended purpose and functionality.
Potentially.
The important question is not simply whether the product uses AI.
Qualification depends on what the software is intended to do and whether its output serves a medical purpose such as diagnosis, prediction, monitoring or treatment.
Sometimes a product can legitimately remain outside medical-device regulation.
But “wellness” is not simply a label.
The functionality, intended purpose, claims, user experience, instructions and marketing all need to support that position.
There is no universal number of patients, samples or validation studies.
The evidence needs to support the intended purpose, claims, risk, population and technology of the particular product.
AI and validationThat depends on whether your product qualifies as a medical device or IVD and how it is classified.
For many regulated devices, independent conformity assessment is required before CE marking.
The important step is to establish the pathway before planning around assumptions.
Talk to FabolaWhether you have an idea, a prototype, a working product, a validation study underway or a Notified Body submission approaching, we can start with the decision you need to make now.
You do not need to know which regulatory service to ask for.
Send us a short description of your product.
