GMED

About

GMED is a leading Certification Organization and a distinguished Notified Body (CE0459) and assesses the conformity of medical devices and in vitro diagnostic medical devices in accordance with European Regulations (EU) 2017/745 and (EU) 2017/746 and carries out the activities required to maintain certificates under Directives (90/385/EEC, 93/42/EEC and 98/79/EC). GMED is also an Auditing Organization Recognized by the MDSAP Regulatory Authority Council and has been performing MDSAP audits since April 2015. GMED is accredited under the NF EN IEC/ISO 17021-1:2015 standard by COFRAC (Certificate № 4-0608), the French Accreditation Committee, to carry out Quality Management System Certification activities according to ISO 9001:2015 and ISO 13485:2016. Established in 1994, GMED is fully owned by LNE, a State-owned Industrial and Commercial Establishment (EPIC), and operates since August 1st, 2018 as a simplified joint-stock company (SAS) within the LNE group. GMED’s success and performance rely on a strong and dedicated team of individuals, trained to the highest level of assessment and auditing methods, to provide the best in medical device certification services: Certification Project Managers, Subject Matters Specialists (MDAO or Medical Device Animal Origin, Medicinal Substance, Active Implantable Medical Devices, Microbiologists), Technical Documentation Evaluators and Design Dossier Assessors, Clinical Reviewers & Experts (Ex: Sterilization Methods and Validation) and Auditors for CE marking and QMS activities. With offices in France and a dedicated US Operation created in 2005 - GMED North America (MD) and a subsidiary created in 2021 – LNE-GMED UK (London), GMED offers the convenience and efficiency of local teams of experimented specialists to accompany your certification process which will allow you to market your technologies into dedicated targeted areas of the world.