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
20th Notified Body designated under EU MDR while IVDR designations lag
Regulatory Updates
US FDA and HHS withdraw proposed 510(k) exemptions for selected Class II medical devices
Regulatory Updates
Medical device adverse event reports increase by 35% in China
Regulatory Updates
Taiwan update: Classification scheme, final fee schedule, post-market surveillance measures