Our Expertise

Clinical research

Our Contract Research Organization (CRO) conducts clinical studies that deliver high-quality clinical data to support pre- and post-market requirements in Europe.

Post-market compliance

Regulatory compliance doesn’t end when your device goes to market. We design compliance solutions informed by a life-cycle approach to device safety and effectiveness.

Human factors research & design

Put a safer, more competitive device in the hands of patients and healthcare providers. Our human factors experts have deep expertise in medical device design.

Related News and Resources

The latest industry insights from our global team.

Regulatory Updates
Health Canada adds private labels to scope of REP pilot program
Regulatory Updates
Latest insights on FDA expectations from the 2020 Virtual HFES Health Care Symposium

Regulatory Updates
European Commissioners loosen some MDD, AIMDD designation renewal requirements for Notified Bodies
Regulatory Updates
IMDRF medical device cybersecurity guidance recommends UL 2900 compliance