THE REGULATORY ONE-STOP-SHOPPING FOR MEDICAL DEVICES COMPLIANCE

Your prestigious partner to reach your business objectives

US and European Device Regulatory

For over 20 years, a recognized resource for reliable and accurate US and European medical technology regulatory expertise, including combination products.

GEMAR also provides highly respected European Authorized Representative services.

Quality Systems

Gemar is a recognized leader in US and European quality system development, implementation, assessment and compliance. Equally proficient with ISO 13485, 21 CFR 820 and PAL 169 quality systems.

Software Compliance

Compliance of medical device software with US and European regulatory requirements needs very specific expertise, which Gemar has available to assist companies, from early development to market clearance.

Environmental Services

A new service for device companies, provided by our experienced Environmental Affairs Associate, helping companies meet the growing list of European environmental directives and standards.

Clinical Studies and IVD Performance Studies in Europe, US and Canada

We are a full-service CRO specializing in medical devices, IVDs and combination products, managing and monitoring clinical studies that are valid for the US and elsewhere. Feel free to contact us and see how we can assist you.