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

The latest industry insights from our global team.

Europe’s MDR and combination products: Clarifications for drug-device product oversight
Spotlight on MDR impact on drug-device combination products
US FDA Finalizes Rule for Post-market Combination Product Safety Reporting
EMERGO SUMMARY OF KEY POINTS: A new US FDA final rule addresses post-market safety reporting obligations for combination products. Reporting requirements for combination products are determined by
FDA Updates PMA and 510(k) Refuse to Accept Policy for Combination Products
EMERGO SUMMARY OF KEY POINTS: US FDA has updated its 510(k) Refuse to Accept and Premarket Approval acceptance policies for combination product submissions. The updated guidances include new
US Regulators Offer Draft Pre-RFD Recommendations for Combination Products
EMERGO SUMMARY OF KEY POINTS: New FDA guidance explains pre-request for designation (Pre-RFD) submission options specifically for combination product manufacturers. All Pre-RFD submissions for