Our Expertise

Clinical research

Our team of experts has decades of experience in providing guidance on clinical evidence collection requirements, designing respective activities, and conducting medical device clinical studies to European requirements.

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
Effective CAPA management: Key steps for medical device manufacturers
Regulatory Updates
In brief: Malaysia MDA introduces new searchable medical device database
Regulatory Updates
TFDA outlines new UDI requirements for medical devices in draft guidance
Regulatory Updates
Brexit Watch: UKNI marking of medical devices placed on the market in Northern Ireland