China's Best One-Stop Medical Equipment Provider
About

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.

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Keywords
medical device certification iso 134852016 qms compliance notified body mdsap regulatory affairs quality innovative technologies in vitro diagnostics eu mdr 2017 745 eu ivdr 2017 746 ce marking marquage ce iso 9001 medical equipment manufacturing regulatory standards regulatory process consulting eu mdr compliance regulatory compliance regulatory gap analysis regulatory frameworks medical device safety training services product registration device classification rules device risk management technical file review regulatory inspection readiness
Company Information
  • Employees 300
  • Founded 1994
  • Annual Revenue $29297000
Location

1 Rue Gaston Boissier, Paris, Ile-de-France, France, 75015

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