What does it take to build a medical AI product when the technology is advancing faster than the regulatory framework around it? Katalin Vikuk speaks with Anette Wolff, QA/RA Manager at Medviso, about how the EU AI Act interacts with the MDR, the difference between closed and continuously learning algorithms, and why validation, documentation and regulatory maturity increasingly affect investment, procurement and hospital adoption. They also examine whether regulation disproportionately favours larger companies—and whether compliance can become a competitive advantage.
AI Act: Constraint or Competitive Advantage?
What does it take to build a medical AI product when the technology is advancing faster than the regulatory framework around it?In this episode, Katalin Vikuk speaks with Anette Wolff, QA/RA Manager at Medviso, about what the EU AI Act means in practice for medical-device companies. They explore the interaction between the AI Act and the Medical Device Regulation, the regulatory difference between closed and continuously learning algorithms, and why validation, data traceability, cybersecurity and documentation are becoming commercially important—not just compliance exercises.
Anette explains why regulatory uncertainty affects startups differently from large incumbents, why clinicians may not be the main barrier to hospital adoption, and why involving regulatory expertise early can become a competitive advantage.
About Anette Wolff
Anette Wolff is QA/RA Manager at Medviso, a Swedish medical-technology company developing software for quantitative MR and CT image analysis and advanced medical 3D modelling. Her work spans regulatory strategy, quality management and compliance for AI-enabled medical-device software across international markets.
Resources mentioned
Medviso: https://medviso.com/
Connect with Anette Wolff: https://www.linkedin.com/in/anette-wolff-1843a94/
EU Artificial Intelligence Act — official text: https://eur-lex.europa.eu/eli/reg/2024/1689/oj
EU Medical Device Regulation — official text: https://eur-lex.europa.eu/eli/reg/2017/745/oj
ISO/IEC 42001 — AI management systems:https: //www.iso.org/standard/81230.html
Reuters investigation mentioned in the episode: https://www.reuters.com/investigations/ai-enters-operating-room-reports-arise-botched-surgeries-misidentified-body-2026-02-09/
About Walk the Valley
Walk the Valley explores what happens between promising healthcare innovation and real-world adoption. Through candid conversations with founders, investors, experts and operators, we examine the regulatory, clinical and commercial obstacles that determine which innovations reach patients.
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Host: Katalin Vikuk
Guest: Anette Wolff
Produced by: Walk the Valley
This conversation was recorded in June 2026 and reflects the regulatory landscape and the speakers’ understanding at that time. It is intended for general information and does not constitute legal or regulatory advice.
