Regulatory pathways
Medical devices, in vitro diagnostics, software and AI-enabled technologies — including classification, conformity assessment and regulatory strategy.
Regulation · Evidence · Commercialisation
From women's health innovation to market reality.
Independent regulatory and commercialisation perspectives on women's health technologies, based in Finland and looking beyond its borders.
Exploring the decisions, evidence and regulatory pathways that shape whether promising technologies can reach patients and markets.
What we're exploring
A focused look at the practical challenges involved in developing and bringing women's health technologies to market.
Evidence and validation
How clinical evidence, performance claims and validation requirements influence product development and investment decisions.
Commercialisation decisions
Connecting regulatory readiness with product positioning, adoption, market access and practical routes to market.
Independent analysis
Case-based perspectives on emerging women's health technologies, with an emphasis on substantive questions rather than industry hype.
Questions worth asking
- When does a women's health app become regulated medical device software?
- What evidence is needed to support claims made for hormone-monitoring technologies?
- Which regulatory uncertainties could materially change a startup's development plan?
- What should founders and investors establish before committing to a market-entry strategy?
Enquiries and collaboration
FemTech Finland is an independent initiative operated by Clarifi Oy, a Helsinki-based regulatory strategy and commercialisation consultancy. The project is being developed; enquiries from founders, investors, researchers and innovation organisations are welcome.
info@clarifi.fiThis is not an official Finnish industry body or a representative organisation for the Finnish FemTech sector. Any advisory services are provided through Clarifi Oy.