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.

Webinars
Applying Human Factors Engineering (HFE) to in vitro diagnostic (IVD) products under the European IVD Regulation (IVDR)
Webinars
Conducting User Research in Difficult Circumstances
White Papers
EU IVDR Conformity Assessment Options for In Vitro Diagnostic Medical Devices
Process Charts
Ukraine IVD regulatory approval process