GMED

GMED is an international certification and notified body focused on the medical device industry. Fully owned by the French National Metrology and Testing Laboratory (LNE), GMED operates as a simplified joint-stock company and has subsidiaries in North America and Asia. The company provides expertise in medical device certification, ensuring compliance with European Medical Device Directives and ISO standards. GMED offers a range of services, including CE marking for medical devices, quality management system certification, and Medical Device Single Audit Program (MDSAP) audits. They also provide regulatory and technical support, evaluating technical documentation and conducting clinical reviews. Additionally, GMED offers tailored training courses to assist manufacturers in meeting certification and regulatory requirements. The company serves a diverse clientele, from small businesses to large multinationals, across various device risk classes and types. Governance is managed by a Supervisory Board appointed by LNE, ensuring high standards and strategic direction. With over 30 years of experience, GMED is committed to supporting medical device manufacturers globally through its comprehensive certification services.