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 regulatory 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.
You may be at the beginning, trying to understand whether your product is a medical device and what CE marking would require.
You may already have a draft technical file, quality management work underway, or a notified body conversation ahead.
You may need a qualified Person Responsible for Regulatory Compliance, or PRRC, but not yet be ready to hire one in-house.
Wherever you are, the first step is the same. Make the regulatory picture clear enough to act on.
How we work
Most founders arrive without answers. That is the right time to talk to us, not the wrong one. The first phase of working together is the phase where the questions get sorted.
We meet you where you are and take it from there. The process is the same whether you arrive with a blank page or with a partial quality management system, draft documentation, 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. What evidence you will need. What quality management and technical documentation requirements are likely to apply. What the route to CE marking looks like for you.
You leave this phase with a plan you can actually use.
Plan the work.
We define the scope, sequence, timeline, and cost of getting you to CE marking. Nothing open-ended. You know what each phase contains before it starts, what decisions need to be made, and what work your team and Fabola will each be responsible for.
Build the foundations.
We do the work alongside your team. Technical documentation, quality management foundations, evidence strategy, notified body engagement, and regulatory decision-making. Existing work is assessed and built on, not automatically thrown out.
Carry it forward.
Once you reach CE marking, or when ongoing regulatory responsibility is needed, we can stay involved as your external PRRC and senior regulatory partner. The team that helped build the strategy can carry the regulatory 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.
About Fabola
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 that 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.
Most files do not need fifty people. They need the right two or three, in the right order, for the right phase.
Ingela Mauritzon, founder
Ingela Mauritzon founded Fabola to bring together the kind of senior, multi-disciplinary regulatory work that small medical device developers usually cannot afford to assemble internally.
She has more than a decade of experience in 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.
That combination matters because CE marking is rarely only a documentation exercise. It is a strategic, clinical, technical, commercial, and organisational problem at the same time.
Fabola works at the point where regulatory strategy, clinical evidence, quality systems, and innovation management meet.
Evidence and training when you need them
Some regulatory questions are really evidence questions. For diagnostics, clinical products, and AI-enabled technologies, we support validation planning, evidence-gap analysis, and regulatory evidence strategy. Independent laboratory work is delivered through Fabola Lab Services, a separate entity.
For teams building internal regulatory capability, we also run focused training and workshops on EU regulation, CE marking, PRRC responsibilities, and regulatory decision-making.
The goal is not only to explain the rules. It is to help teams build the judgement to make better regulatory decisions as the product, evidence, and company develop.
Selected insights
The regulatory journey
Understanding the phases and milestones of bringing a medical device to the European market.
Read Insight arrow_forwardThe PRRC role explained
A practical explanation of what regulatory responsibility means under MDR and IVDR.
Read Insight arrow_forwardRegulatory strategy for AI & diagnostics
Why evidence strategy matters for diagnostic and AI-enabled medical devices.
Read Insight arrow_forwardStart the conversation
The first conversation is free.
You do not need to have a complete regulatory plan before speaking with us. We use the call to understand your product, your company, where you are in the journey, and what you are trying to achieve.
You leave it with a clearer picture of what the regulatory path looks like for you, and what working together would involve.