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.
How Fabola works with clients
Directly with senior expertise
The person who scopes the work leads it. There is no hand-off to a junior team once the proposal is agreed.
Specialists when they are needed
Where a question needs specific expertise, such as statistics or a particular clinical field, it is added for that piece of work rather than built into every engagement.
Defined pieces of work
Engagements start with a defined question, an agreed scope and deliverable, and, where the scope can be bounded, an agreed fee.
Starting from what exists
Existing documentation, evidence, QMS work and earlier regulatory analysis are reviewed before any new work is recommended.
Rooted in Europe, with the US and China in view.
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 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.
Work directly with senior regulatory expertise.
Tell us what the product is, where the project stands and the regulatory question you need answered.
The first conversation is free and carries no commitment.