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
New Brazil INMETRO ordinance eases inspection and documentation requirements
Regulatory Updates
US FDA unveils next steps for regulating artificial intelligence-based medical software
Regulatory Updates
European Commission announces appointments to medical device, IVD Expert Panels
Regulatory Updates
Home Healthcare Products Take Center Stage