Regulation is not the obstacle.
Uncertainty is.
Fabola is the senior regulatory partner for medical device developers who want a clear path through EU regulation — and someone trusted to walk it with them.
The path is long. We make it legible.
EU regulation for medical devices and diagnostics is dense, layered, and unforgiving. The journey through it has a clear shape — once someone shows it to you.
Trying to understand whether your product is a medical device under EU law, and what CE marking would require of you.
You have a draft technical file, quality-management work underway, or a notified-body conversation ahead.
You need a qualified Person Responsible for Regulatory Compliance (PRRC), but aren’t ready to hire one in-house.
Wherever you are, the first step is the same — make the regulatory picture clear enough to act on.
Most founders arrive without answers.
That is the right time to talk to us, not the wrong one. We meet you where you are — whether you arrive with a blank page or a partial quality-management system and a notified-body conversation already underway.
Map your route
We build the regulatory picture together: what kind of product you have under EU law, what it is intended to do, what claims you can make, how it may be classified, and what evidence you will need. You leave with a plan you can actually use.
Plan the work
We define the scope, sequence, timeline, and cost of reaching CE marking. Nothing open-ended — you know what each phase contains before it starts, and who is responsible for what.
Build the foundations
We do the work alongside your team: technical documentation, quality-management foundations, evidence strategy, and notified-body engagement. Existing work is assessed and built on, not thrown out.
Carry it forward
Once you reach CE marking, we can stay on as your external PRRC and senior regulatory partner — carrying the work forward with continuity, judgement, and accountability.
The first phase has standalone value.
If you decide to stop there, you leave with a clear plan and the documentation to support it. For most clients, it is the start of a longer relationship.
Fabola is a senior regulatory practice for medical device developers. We work as a focused team, with a wider network of regulatory, clinical, quality, and laboratory experts we bring in when a file needs them.
That structure is deliberate. A senior team gives you continuity, judgement, and a single point of accountability. The network gives you specialist depth — without the overhead of a large consultancy.
A senior, multidisciplinary practice — by design.
Ingela Mauritzon founded Fabola to bring together the kind of senior, multidisciplinary regulatory work that small medical device developers usually cannot afford to assemble internally.
She has more than a decade of experience across MedTech regulation, clinical diagnostics, and healthcare innovation — including co-founding and running IVD laboratories. Her background spans the UK, Europe, Singapore, and China, with academic work in innovation science alongside regulatory practice.
CE marking is rarely only a documentation exercise. It is a strategic, clinical, technical, commercial, and organisational problem at once — and Fabola works where those meet.