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
UK regulators issue new consultation on updated medical device regulations slated for July 2023

Sun Sep 19
Regulatory Updates
Crafting effective use scenario prompts: A key to medical device usability test success

Wed Sep 15
Regulatory Updates
IVDR watch: IVD Expert Panel now accepting submissions for performance evaluation consultations

Mon Sep 13
Regulatory Updates
Singapore HSA recommends cybersecurity protections against BrakTooth for Bluetooth medical devices

Tue Sep 07