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
Chinese regulatory bodies provide updates on revised medical device regulations
Regulatory Updates
ISO 20916: IVD medical device clinical performance studies at a glance
Regulatory Updates
Health Canada issues progress report on its Medical Devices Action Plan
Regulatory Updates
Australian Conformity Assessment Body (AU CAB) applications begin in July