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
US FDA outlines next steps following COVID-19 Pandemic Recovery and Preparedness Plan (PREPP)
Regulatory Updates
NMPA publishes guidelines for Device Master File (DMF) submissions
Regulatory Updates
US FDA Emergency Use Authorization (EUA) routes for medical devices: Updated overview
Market Data
2021 Medical Device Industry Outlook