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
In brief: China NMPA seeks feedback on optimization of medical device standards
Regulatory Updates
New guidelines published on integrating UDI into quality management systems under MDR, IVDR in Europe
Regulatory Updates
Singapore HSA holds consultation on SaMD classification draft guidance
Regulatory Updates
SFDA revises guidance on storing and transporting medical devices