Launchpad for digital health and AI
From software approval to hospitals that integrate and pay.
For digital health, healthtech, and healthcare AI companies, including software as a medical device, up to two years past CE mark or FDA clearance. A Senior Partner leads every engagement.
HealthSeed
Launchpad · Digital health and AI
- 6phases, each with a goal
- 1Senior Partner leads
- 35+Expert Community specialists
Where digital health and AI launches stall
Software crosses borders easily. Approval, data, and payment do not.
Each of these sits between a working product and a hospital that uses it and pays for it.
Software qualification and class
Whether the software is a medical device, and which MDR class it takes.
Chapter 1EU AI Act and cybersecurity
When device software is a high-risk AI system, which dates apply, and how MDR cybersecurity fits.
Chapter 10Data protection and hospital integration
Software adapted for Europe: data protection, integration with hospital systems, and compliance.
Entering EuropeA payment route for software
Some countries pay for digital health applications through dedicated routes; most do not.
Chapter 13
The Launchpad route
Six phases, each ending in a goal your board can check.
For software, the regulatory phase also covers AI Act obligations and the integration and data terms hospitals require.
01
Strategy
Goal: first-market decision and a map of who pays
02
Regulatory
Goal: plan in place, an EU authorised representative appointed
03
Market access
Goal: reimbursement route confirmed
04
Customer pilots
Goal: a hospital pilot agreed, with the terms that turn it into a purchase
05
Launch
Goal: first purchase orders
06
Handoff
Goal: your team runs the next country
Read the evidence first
The digital health and AI chapters of From CE Mark to Revenue.
Our free reference book sets out the rules each phase rests on, with every source linked.
- Read chapter 1
Qualification, device class, and roles
Whether software qualifies as a medical device and which class applies.
- Read chapter 10
EU AI Act and cybersecurity rules for devices
When device software is a high-risk AI system and which dates apply.
- Read chapter 13
Device and IVD reimbursement by EU country
National payment routes, including those for digital health applications.
What happens next
- You tell us your product, its approval, and your first market
- A Senior Partner replies with the questions your board will ask
- You receive a written proposal for the phases you need
Next step
Talk to a Senior Partner about your software.
Or answer six questions in Plan your launch and see an indicative route first. A Senior Partner reads every enquiry and replies.
Talk to a Senior Partner