Common Pitfalls
- Vague intended use leading to misclassification
- No QMS or weak cybersecurity
- Poor clinical evidence strategy
- 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.
