Your European launch team, from the first plan to the first hire.
For medtech, diagnostics, and digital health companies arriving from the United States, the Middle East, or Asia, with no one on the ground in Europe. Health companies up to two years past CE mark or FDA clearance, building repeatable sales.
What changes when you cross into Europe.
Almost everything around the product is built again for each market.
Approval
At home: FDA clearance
Europe asks: CE marking under MDR or IVDR
Representation
At home: Your own entity
Europe asks: An EU authorised representative
Payment
At home: Known payer routes
Europe asks: Reimbursement decided country by country
Hospital buying
At home: Known buyers
Europe asks: Public tenders and local procurement rules
Data and software
At home: Home privacy rules
Europe asks: GDPR, hosting rules, integration, and the AI Act
What we run for you, in the order it happens.
Each stage depends on the one before it, and your board sees progress against every milestone.
Plan
EU market readiness plan
First market, payer route, regulatory gaps, and the evidence Europe will ask for.
Milestones and budget
A launch plan your board can fund, with each milestone costed against your runway.
Establish
Presence and representation
EU representation through specialist partners, and help hiring local representatives as you set up.
Software adapted for Europe
Data protection, hospital integration, and compliance for your software.
Sell
Hospital mapping and first outreach
Using our own hospital profiling method, we map the key contacts in each target hospital and run the first outreach with you.
Board and investor reporting
Progress against milestones in the form your board expects.
Hand over
Hiring plan and first hires
The roles you need, in what order, and the search for your country lead.
Software that European hospitals can switch on.
Digital health and AI products often clear regulation and then stall at the hospital IT department. We adapt your product before that conversation starts.
- GDPR compliance and national hosting rules, such as HDS certification in France and C5 attestation in Germany
- Integration with hospital information systems through HL7 FHIR and other interoperability standards
- Cybersecurity review against hospital procurement requirements
- AI Act obligations for AI-enabled products
- Language and clinical workflow localisation
Delivered with specialist technical partners, confirmed at kickoff, subject to mutual agreement.