Our Expertise

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.

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

The latest industry insights from our global team.

Medical Device Incident Reporting in Europe
First in a two part article that d iscusses when medical device and IVD manufacturers should report inclidents involving their devices as specified in the Medical Devices Directive (93/42/EEC).
Medical Device Clinical Evidence Requirements: Are You Prepared?
Article discusses the changing requirements for clinical evidence for medical devices marketed in Europe.
Europe issues new guidance document on medical device post market surveillance and vigilance.
The European Commission has issued a revised version of MEDDEV 2.12-1 which provides guidance to industry and Competent Authorities on how to meet the medical devices vigilance system requirements.
Wearables vs. Regulated Medical Devices under the US FDA
One of th e biggest challenges for companies in the general wellness space is understanding how and when their technology might encounter FDA