Why SaMD Launches Fail in Europe

ByPiotr Wrzosinski

Common Pitfalls

  1. Vague intended use leading to misclassification
  2. No QMS or weak cybersecurity
  3. Poor clinical evidence strategy
  4. Failure to engage clinicians or users

Fixes:

  • Start regulatory early
  • Build real clinical value
  • Design with adoption in mind

Learn more at Scaling MedTech: From Product to Market

This post is part of SaMD Europe Launch Guide.

This content has been enhanced by GenAI tools.

Piotr Wrzosinski

Piotr Wrzosinski is a life sciences commercial and digital transformation leader with 20+ years of experience across pharma, medtech, and consulting. He writes about medtech, digital health, commercialization, AI, and regulation in Europe through an operator lens focused on adoption, evidence, and scale.