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 Contract Research Organization (CRO) conducts clinical studies that deliver high-quality clinical data to support pre- and post-market requirements in Europe.

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.

Tools
EU IVDR Readiness Assessment Checklist
Regulatory Updates
Europe’s MDR and combination products: Clarifications for drug-device product oversight
White Papers
Regulations for Companion Diagnostics in the US and EU