Reetta Hintsanen
Reetta Hintsanen is the COO of Gosta Labs (M. Sc. Tech, Information networks), where she leads engineering, regulatory affairs, and customer operations with one clear mission: bringing safe, trustworthy AI to hospitals: bridging technical fluency with the complexity of healthcare compliance — and making both move faster.
Before Gosta Labs, Reetta spent eight years at Kaiku Health and Elekta, scaling commercial operations for another regulated medical device to over 35 countries. As part of her role, she scaled a commercial open ecosystem model that unlocked real-world data across stakeholders to improve cancer care - while keeping always the patient and their privacy first.Topics
Regulatory Strategy as a Market Access Engine: Lessons from Scaling Medical AI in European Healthcare
For medical AI companies, regulatory strategy is often treated as a hurdle to clear before going to market. This session argues it can be much more than that: a deliberate choice that shapes product development and customer trust. Drawing on Gosta Labs’ experience bringing AI clinical documentation and workflows into everyday healthcare, Reetta Hintsanen shares practical lessons on matching regulatory decisions to business goals. The session covers how to stay compliant with fast-moving AI technology under the MDR and the upcoming AI Act, and what healthcare customers expect from AI vendors.