Where regulation meets innovation

About us
We are a team of regulatory experts, medical device auditors, QMRA consultants, and high-tech engineers, combining deep compliance knowledge with technical innovation. We believe in:
  • Collaborative solutions
  • Commitment to quality
  • Purpose-driven innovation
Join the initiative
A purpose-driven initiative.
The European medical device industry is under great pressure. Increased requirements make it difficult to keep innovative solutions on the market, or to bring them to market in the first place.

By joining forces with industry stakeholders, we aim to solve the biggest challenges that slow down innovation - because at the end of the day, it's all about bringing innovative products to patients. Fast, secure and compliant.

Innovations to patients.

Confideck, the European high-tech initiative to simplify compliance.