# HealthSeed AG

> Swiss healthcare venture studio and commercialisation partner. Europe is open now. The US is in preparation, and MENA partnerships are under way.

- [Facts for AI assistants](https://www.healthseed.vc/for-ai-assistants): who HealthSeed is, what it does, and how to describe it

## Main pages

- [Home](https://www.healthseed.vc/): HealthSeed takes approved health products to their first paying customers abroad, and builds the companies the market has not.
- [Launchpad](https://www.healthseed.vc/launchpad): One programme, run by one accountable team, that takes your product to paying customers.
- [Services](https://www.healthseed.vc/services): Take the whole route, or bring us in for one step. A Senior Partner leads every engagement.
- [Foundations](https://www.healthseed.vc/services/foundations): You bring the decision in front of you. You leave with the plan, the owners, and the next steps.
- [Intelligence](https://www.healthseed.vc/services/intelligence): The HealthSeed Intelligence Engine reads the sources at scale. People who have launched products there tell you what it means.
- [Communications](https://www.healthseed.vc/services/communications): Written by people who have launched products in these markets, with every claim checked against your evidence.
- [DeckScore](https://www.healthseed.vc/deckscore): A score out of 60 across twelve sector-weighted dimensions, the investor your deck was written for, and a slide-by-slide rewrite plan.
- [Plan your launch](https://www.healthseed.vc/plan-your-launch): See an indicative regulatory and payer route for your product.
- [For investors](https://www.healthseed.vc/investors): Senior operators inside the companies you hold, for faster first revenue and less capital spent on market entry.
- [Ventures](https://www.healthseed.vc/ventures): Where the science is exceptional and the company is not ready, we build alongside it and take equity with the founders.
- [Partnerships](https://www.healthseed.vc/partnerships): A launch needs more disciplines than any single firm employs. We lead the route and bring in partners at the phase where they are needed, under one contract and one standard.
- [About](https://www.healthseed.vc/about): Founded by two senior healthcare executives who spent decades taking health products from approval to revenue.
- [Daren Wilson](https://www.healthseed.vc/daren-wilson): Twenty-eight years inside pharmaceutical companies learning how health systems buy innovation. I now work with the companies trying to sell it to them.
- [Safia Agueni](https://www.healthseed.vc/safia-agueni): Close to two decades inside Novartis and Roche on the parts of healthcare that decide whether a technology can be used. I now do that work with founders and health systems.
- [Insights](https://www.healthseed.vc/insights): Operator analysis of European health markets, from regulation and reimbursement to AI and venture building.
- [Contact](https://www.healthseed.vc/contact): Choose the row that describes you, or write to us directly. A Senior Partner reads every enquiry and replies.

## From CE Mark to Revenue

> From CE Mark to Revenue: The regulatory and commercial route for medical devices, software and in vitro diagnostics in the European Union. A free reference book by Daren Wilson, published by HealthSeed AG under CC BY 4.0. Each chapter answers one question and cites the official text behind every statement.

- [From CE Mark to Revenue](https://www.healthseed.vc/resources/from-ce-mark-to-revenue): the book home, with the chapters by stage
- [Introduction](https://www.healthseed.vc/resources/from-ce-mark-to-revenue/introduction): Markdown copy at https://www.healthseed.vc/book/from-ce-mark-to-revenue/md/introduction.md
- [Chapter 1: Is it a medical device, which class, and who is responsible?](https://www.healthseed.vc/resources/from-ce-mark-to-revenue/01-scope-product-company): Markdown copy at https://www.healthseed.vc/book/from-ce-mark-to-revenue/md/01-scope-product-company.md
- [Chapter 2: Which market should come first, and on what evidence?](https://www.healthseed.vc/resources/from-ce-mark-to-revenue/02-choose-market-sequence): Markdown copy at https://www.healthseed.vc/book/from-ce-mark-to-revenue/md/02-choose-market-sequence.md
- [Chapter 3: How large is the opportunity, and what can the published figures support?](https://www.healthseed.vc/resources/from-ce-mark-to-revenue/03-size-opportunity): Markdown copy at https://www.healthseed.vc/book/from-ce-mark-to-revenue/md/03-size-opportunity.md
- [Chapter 4: What quality system does the law require, and who answers for it?](https://www.healthseed.vc/resources/from-ce-mark-to-revenue/04-quality-system): Markdown copy at https://www.healthseed.vc/book/from-ce-mark-to-revenue/md/04-quality-system.md
- [Chapter 5: Which standards do the risk, usability, software and security files rest on, and how is the answer kept current?](https://www.healthseed.vc/resources/from-ce-mark-to-revenue/05-standards-evidence-files): Markdown copy at https://www.healthseed.vc/book/from-ce-mark-to-revenue/md/05-standards-evidence-files.md
- [Chapter 6: What evidence shows the device is safe and works, and how is it kept current?](https://www.healthseed.vc/resources/from-ce-mark-to-revenue/06-clinical-performance-evidence): Markdown copy at https://www.healthseed.vc/book/from-ce-mark-to-revenue/md/06-clinical-performance-evidence.md
- [Chapter 7: What goes into the technical documentation, and how is it kept current?](https://www.healthseed.vc/resources/from-ce-mark-to-revenue/07-technical-documentation): Markdown copy at https://www.healthseed.vc/book/from-ce-mark-to-revenue/md/07-technical-documentation.md
- [Chapter 8: Which notified body can assess the device, and how does the work with it run?](https://www.healthseed.vc/resources/from-ce-mark-to-revenue/08-notified-body): Markdown copy at https://www.healthseed.vc/book/from-ce-mark-to-revenue/md/08-notified-body.md
- [Chapter 9: Who registers the company, its partners and each device, and by when?](https://www.healthseed.vc/resources/from-ce-mark-to-revenue/09-register-actors-device): Markdown copy at https://www.healthseed.vc/book/from-ce-mark-to-revenue/md/09-register-actors-device.md
- [Chapter 10: Which AI and cybersecurity rules reach the product, and from when?](https://www.healthseed.vc/resources/from-ce-mark-to-revenue/10-ai-cybersecurity): Markdown copy at https://www.healthseed.vc/book/from-ce-mark-to-revenue/md/10-ai-cybersecurity.md
- [Chapter 11: After launch, what must a manufacturer monitor, report and correct?](https://www.healthseed.vc/resources/from-ce-mark-to-revenue/11-operate-after-launch): Markdown copy at https://www.healthseed.vc/book/from-ce-mark-to-revenue/md/11-operate-after-launch.md
- [Chapter 12: Does Union health technology assessment reach the product?](https://www.healthseed.vc/resources/from-ce-mark-to-revenue/12-union-hta): Markdown copy at https://www.healthseed.vc/book/from-ce-mark-to-revenue/md/12-union-hta.md
- [Chapter 13: Which national route does the product take, and who pays at the end?](https://www.healthseed.vc/resources/from-ce-mark-to-revenue/13-national-route): Markdown copy at https://www.healthseed.vc/book/from-ce-mark-to-revenue/md/13-national-route.md
- [Chapter 14: Which economic evidence can be built once, and what does each country set?](https://www.healthseed.vc/resources/from-ce-mark-to-revenue/14-economic-evidence): Markdown copy at https://www.healthseed.vc/book/from-ce-mark-to-revenue/md/14-economic-evidence.md
- [Chapter 15: How do public buyers purchase the product, and what must be ready before the notice?](https://www.healthseed.vc/resources/from-ce-mark-to-revenue/15-procurement): Markdown copy at https://www.healthseed.vc/book/from-ce-mark-to-revenue/md/15-procurement.md
- [Chapter 16: Which countries come first, and who sells at what price?](https://www.healthseed.vc/resources/from-ce-mark-to-revenue/16-markets-channels-price): Markdown copy at https://www.healthseed.vc/book/from-ce-mark-to-revenue/md/16-markets-channels-price.md
- [Chapter 17: What will European market entry cost, what does it wait on, and who can pay?](https://www.healthseed.vc/resources/from-ce-mark-to-revenue/17-cost-dependency-funding): Markdown copy at https://www.healthseed.vc/book/from-ce-mark-to-revenue/md/17-cost-dependency-funding.md
- [Chapter 18: Which commitments in the entry programme should be checked before options close?](https://www.healthseed.vc/resources/from-ce-mark-to-revenue/18-audit-entry-programme): Markdown copy at https://www.healthseed.vc/book/from-ce-mark-to-revenue/md/18-audit-entry-programme.md