Our Expertise

Regulatory strategy

We understand how drug, device, and biologic requirements overlap in the US, Europe, and beyond. We’ll help you define where your product stands in the regulatory landscape.

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.

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: Nearly 700 breakthrough medical device designations since 2015

Thu Aug 11
Regulatory Updates
Three tips to prevent test artifact from ruining your HF validation test

Thu Jul 21
Regulatory Updates
Wiklund’s perspective: Effective user interface design versus curiosity

Fri Jul 15
Regulatory Updates
Conducting clinical performance studies in compliance with European regulatory requirements

Thu Jul 14