Regulatory work with a defined outcome

Fabola provides regulatory services for medical device, IVD and health technology companies bringing products to market in Europe, with additional experience connecting EU regulatory strategy to the United States and China.

We work particularly with startups, scaleups and international manufacturers developing software, AI-enabled medical devices, medical device software (MDSW, often called SaMD), in vitro diagnostic medical devices and other regulated health technologies.

Our model is simple: define the regulatory question first. Before work begins, you know what information we need, what Fabola will do, what you will receive, what it will cost, when it will be delivered and what marks the end of the assignment.

Start with the question you need answered

Each work package answers one defined regulatory question, at a price agreed before work begins. External PRRC is different: an ongoing regulatory role, priced per month.

Classification & conformity pathway

Is my product a medical device or IVD, what class is it, and what do I need to do to place it on the EU market?

Most early-stage companies start here

SEK 29,000–59,000

Qualification, intended purpose, classification, applicable rule, conformity assessment route and next steps.

MDR / IVDR readiness

How far are we from being ready for CE marking under the MDR or IVDR?

SEK 49,000–119,000

Gap assessment of regulatory strategy, QMS and technical documentation with a prioritised route to submission readiness.

Clinical / performance evidence

What evidence do we actually need to support our medical device or IVD?

SEK 49,000–99,000

Evidence gap assessment and strategy linking intended purpose and claims to the evidence required.

AI validation & evidence

How do we demonstrate that our AI-enabled medical device works reliably and safely for its intended medical use?

SEK 59,000–119,000

Regulatory validation strategy for AI-enabled medical devices, including datasets, metrics, acceptance criteria and evidence traceability.

EU AI Act + MDR / IVDR

How does the EU AI Act interact with the MDR or IVDR for our product?

SEK 39,000–79,000

Applicability, overlap and gap mapping across the AI Act and medical device regulatory framework.

Notified Body readiness

Are we ready to submit to a Notified Body?

SEK 59,000–139,000

Independent pre-submission review of technical documentation and likely assessment questions.

Regulatory intelligence

We have one defined regulatory question. Can you answer it without turning it into a six-month consulting project?

Best for one specific question

SEK 19,000–59,000

Focused answer to a defined regulatory or market-entry question, with primary sources and recommendation.

External PRRC

Do we need a Person Responsible for Regulatory Compliance, and can Fabola fulfil that role?

Ongoing support, not a one-off package

SEK 18,000–55,000 / month

Ongoing Person Responsible for Regulatory Compliance function for eligible MDR and IVDR manufacturers.

All prices are in SEK and exclude VAT.

How an engagement works

  1. Scoping conversation

    You describe the product and the question you need answered. The first conversation is free and carries no commitment.

  2. Written proposal

    We confirm the question and set out the information we need, what Fabola will do, what you will receive, the agreed fee and the delivery date.

  3. Delivery

    We carry out the analysis and deliver the written output agreed in the proposal, with the reasoning behind each conclusion.

  4. Handover

    We walk you through the findings in a review session. The assignment ends there, with a clear view of the next step if there is one.

Frequently asked questions

Does Fabola charge by the hour?

Most services are sold at a fixed fee. The scope, deliverables, completion point and price are agreed before work begins. Work outside the agreed scope is quoted separately.

Can an early-stage startup use these services before it has a complete technical file?

Yes. Several services are designed specifically for early-stage companies. Classification, conformity pathway and evidence strategy can be done before a complete technical file exists.

Does Fabola only work with EU regulation?

The core services on this page focus on EU MDR, IVDR and the EU AI Act. Fabola also works with international market-entry questions, particularly where EU strategy needs to be connected to the United States or China.

Can Fabola guarantee CE marking or Notified Body certification?

No. Certification and conformity assessment decisions remain with the relevant authorities and designated Notified Body. Fabola can define the pathway, improve readiness and help the manufacturer address regulatory gaps.

Ready to define the work?

Tell us what the product is, where the project stands and the regulatory question you need answered.

You do not need to know the name of the service. If the project needs a broader scope than one work package, we will say so.

Discuss a project

The first conversation is free and carries no commitment.