GMED

GMED is a Notified Body (0459) and international certification body providing medical device conformity assessment and regulatory compliance services to manufacturers worldwide. The organisation has over 30 years of experience in the field and employs 350 dedicated experts, working with clients across Europe, Asia, North America and globally.

Its services cover the principal routes to market for medical device manufacturers. These include CE marking conformity assessment for the European market, certification of medical device quality management systems to ISO 13485, and Medical Device Single Audit Program (MDSAP) auditing conducted across five countries. GMED also works in the areas of medical device safety and performance evaluation, supporting manufacturers through the regulatory requirements that govern their products.

The company's stated approach rests on rigor, expertise, and integrity and independence in certification. Its work is directed towards patient safety and health outcomes, and towards helping manufacturers navigate regulatory hurdles efficiently. GMED operates in the medical devices, healthcare and medical device manufacturing sectors.