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
ANVISA suspends expedited registrations for COVID-19 products
Regulatory Updates
An assessment of the proposed rule to change US FDA’s interpretation of Intended Use
Regulatory Updates
2020 amendments to IEC 62366 – implications for medical device usability engineering
Regulatory Updates
South Korea’s MFDS publishes draft regulatory revision and new guidance documents