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.

White Papers
Conceptual design of a product’s user interface
Regulatory Updates
Impact of COVID-19 emergency on US FDA interactions with medical device manufacturers

Regulatory Updates
US FDA publishes final guidance outlining standard inspection procedures
Regulatory Updates
Design verification and validation versus human factors validation