Typical questions
- What regulatory pathway applies in this market?
- How are comparable products classified?
- Which Notified Bodies are designated for this device or IVD scope?
- What does a regulatory change mean for our product?
- How does the EU approach compare with the United States or China?
- What evidence are regulators or assessors expecting for this technology?
- What does a new policy mean commercially?
Required inputs
- The decision or question to be answered
- Relevant product or company context
- Target market
- Deadline, if the question is time-sensitive
- Any existing internal analysis or assumptions that should be tested
What Fabola does
We define the question narrowly, identify primary regulatory and policy sources, triangulate secondary evidence where useful, and produce an answer designed to support a real decision rather than a generic literature summary.
Deliverables
- Regulatory intelligence memo
- Source list with links
- Market-entry or pathway analysis
- Comparative regulatory analysis where relevant
- Board or management briefing
- Clear recommendation and next-step options
Price
Focused regulatory answer
SEK 19,000
One narrow question with limited source set and concise written answer.
Standard regulatory intelligence memo
SEK 29,000
Typical assignment: defined question, primary-source research, analysis, written recommendation and one review meeting.
Complex comparative analysis
SEK 39,000–59,000
Multiple jurisdictions, extensive market mapping, several product pathways or a materially broader evidence base.
All prices are in SEK and exclude VAT.
Delivery time
Typical delivery: 5–10 business days. Broader comparative assignments are usually delivered within 2–3 weeks.
Completion point
The assignment is complete when the agreed research question has been answered in writing, sources have been provided and the recommendation has been discussed in one review meeting.
Exclusions
- Formal legal opinion
- Complete product-specific conformity assessment
- Full technical-documentation development
- Ongoing monitoring unless separately commissioned
Likely next step
No further work may be necessary. If the analysis identifies a defined regulatory project, it can lead into one of Fabola’s other fixed-scope services.
Frequently asked questions
Can you answer a single regulatory question without a retainer?
Yes. That is the purpose of this service. A standard regulatory intelligence memo is normally SEK 29,000 and is scoped around one defined decision.
Can you compare EU, US and China pathways?
Yes. Comparative work is particularly useful when a company is deciding market sequence, evidence reuse or where to establish its first regulatory pathway.
Do you use primary sources?
Yes. Fabola prioritises legislation, regulator and competent-authority materials, official databases, standards and other authoritative sources, with secondary evidence used where it adds context.
Can you monitor a regulatory development after the memo is delivered?
Yes, but ongoing monitoring is outside the fixed memo scope and is quoted separately if needed.
Other services
Classification and 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?
MDR and IVDR readiness
How far are we from being ready for CE marking under the MDR or IVDR?
Clinical and performance evidence
What evidence do we actually need to support our medical device or IVD?
AI validation and evidence
How do we demonstrate that our AI-enabled medical device works reliably and safely for its intended medical use?
EU AI Act + MDR / IVDR
How does the EU AI Act interact with the MDR or IVDR for our product?
Notified Body readiness
Are we ready to submit to a Notified Body?
PRRC
Do we need a Person Responsible for Regulatory Compliance, and can Fabola fulfil that role?
What are you building?
Whether you have an idea, a prototype, a working product, a validation study underway or a Notified Body submission approaching, we can start with the decision you need to make now.
You do not need to know which regulatory service to ask for.
Send us a short description of your product.