Confirm the route
Establish what applies to the product, how it is classified and which conformity assessment route follows.
Start where you are.
Most regulatory questions fall into one of three areas. Each leads to defined services, with their inputs, deliverables and prices set out on the service pages.
Build the evidence
Work out what clinical, performance or AI validation evidence the intended purpose and claims actually require.
Prepare for assessment
Find out what stands between your current documentation and conformity assessment, and close the gaps that matter.
Regulatory work should not be open-ended.
Most Fabola engagements begin with a defined question.
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Clear scope
We agree what question is being answered and what is included.
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Defined deliverable
You know what you will receive and what decision it should support.
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Predictable fee
Where the scope can be bounded, the price is agreed before work begins.
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Known timeline
The delivery period starts when the agreed complete inputs are received.
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Clear finish
The engagement ends when the agreed work has been delivered.
If another regulatory problem needs to be solved, we can define the next piece of work. If not, the engagement ends there.
We start from what you already have.
Existing documentation, evidence, QMS work and previous regulatory analysis are reviewed before any new work is recommended.
Defined-scope work starts at SEK 19,000, excluding VAT. The first conversation is free and carries no commitment.
Services and typical pricesSpecialist depth where it matters.
AI medical devices
A model performing well is not the same thing as a medical device being adequately validated.
Fabola works where intended purpose, datasets, clinical evidence, model performance, lifecycle change and MDR/IVDR–AI Act requirements meet.
Explore AI medical devicesEvidence & validation
More validation is not automatically better validation.
The question is whether the evidence supports the intended purpose, the claims, the population and the regulatory pathway.
Explore evidence & validationRegulatory intelligence
Comparable products and public regulatory information can answer defined strategic questions.
One question, a bounded analysis, primary sources and a clear recommendation.
Explore regulatory intelligence
Senior-led, from the first conversation to the final deliverable.
Ingela Mauritzon Founder, Fabola
Fabola is led by Ingela Mauritzon, a medical-device regulatory specialist and researcher working at the intersection of regulation, artificial intelligence and innovation.
- You work directly with senior regulatory expertise.
- Specialist expertise is added when the question genuinely needs it.
- Work is not passed down through a large consulting hierarchy.
Need Fabola to take on a broader regulatory programme?
Fabola also supports larger engagements involving multiple connected workstreams, including:
- MDR / IVDR remediation
- Technical documentation development
- CE-marking execution
- Notified Body interaction
- Regulatory programme leadership
- AI-enabled medical-device programmes
- Ongoing regulatory support
You do not need to start with a smaller work package first.
Not sure where to start?
You do not need to know the name of the service.
Tell us what the product is, where the project stands and what regulatory decision needs to be resolved.
We will point you toward the most relevant starting point, or tell you if the project needs a broader scope.
Common questions
Questions about whether a product is regulated, and how, are answered in Knowledge.
Regulatory questions, answeredDo we need to know which service we need?
No. Tell us what the product is, where the project stands and what regulatory decision needs to be resolved.
We will point you toward the most relevant starting point, or tell you if the project needs a broader scope.
Is the price agreed before work begins?
Where the scope can be bounded, yes. The question, scope, deliverable, fee and delivery time are agreed in writing before work starts, and work outside that scope is quoted separately.
Typical prices for each service are published on its service page. All prices are in SEK and exclude VAT.
Services and pricesWhen does the delivery time start?
When we have received the complete inputs agreed for the engagement. Each service page lists the inputs it needs, so you know in advance what to prepare.
Will you redo work we have already done?
No. We start from what you already have. Existing documentation, evidence, QMS work and previous regulatory analysis are reviewed before any new work is recommended.
Can Fabola take on a larger regulatory programme?
Yes. MDR or IVDR remediation, technical documentation, CE-marking execution, Notified Body interaction, regulatory programme leadership and ongoing support can be scoped as a broader engagement.
You do not need to start with a smaller work package first.
What regulatory question needs resolving?
Tell us what the product is, where the project stands and the decision you need to make.
We will propose a defined piece of work, or tell you if the project needs a broader scope.
Discuss a project
The first conversation is free and carries no commitment.