GMED, an organization with numerous recognitions in the medical industry
- A French notified body (0459) for assessing medical device compliance with applicable Regulations (EU) 2017/745 and (EU) 2017/746 and European directives (90/385/EEC, 93/42/EEC and 98/79/EC).
- An international reference body in the certification of health care and medical device quality management systems under ISO 9001, NF EN ISO 13485 and ISO 13485.
- An MDSAP Auditing Organization
Assessment of Quality Management Systems for medical device manufacturers based on the regulations of the following 5 countries: Australia, Brazil, Canada, Japan, and the United States.
- A conformity assessment body under mutual recognition agreements signed between the European Union and both Australia and New Zealand
- A Technical Cooperation Program (TCP) certification body: Taiwan
GMED is accredited by Taiwan’s Ministry of Health to perform ISO 13485 audits.
- Partnerships: GMED certificates are recognized by some certification bodies in Ukraine.
- Training Organization
GMED’s expertise is available to help develop your skills in the field of risk management and the implementation of European medical device regulation.
GMED’s experienced specialists in Europe and North America are ready to support you efficiently as you work towards your certification project to take your medical devices to your target markets.
GMED’s success and high performance rely on the excellence and commitment shown by its teams, who are highly trained in current assessment and certification methods.
GMED, an LNE subsidiary
The French National Metrology and Testing Laboratory (LNE), the parent company of GMED SAS, was created in 1901. LNE is a state-owned industrial and commercial institution, under the authority of the Economy and Finances Ministry in charge of Industry. Built on an excellent scientific and technical skill set, LNE’s work has provided a solid foundation for a variety of activities: calibration, testing, certification, etc. LNE is renowned for its expertise both in France and around the world, performing measurements that serve the economy and society.
After 25 years as part of LNE’s Certification department, GMED, with its branch GMED NA, became a wholly-owned subsidiary of LNE* in the form of a simplified joint-stock company (SAS) on August 1, 2018.
*LNE, as a holding entity of GMED, and GMED, in its role as a notified body and accredited certification organization, must maintain impartiality in GMED’s work. Consequently, they shall not carry out any consulting activities that, by their nature, could compromise this impartiality.
Learn more about LNE’s activities in health care and medical fields including testing of medical devices
Over the years
Medical equipment test laboratory group GLEM is formed.
The EIG (Economic Interest Group) G-MED is established with four partners: the Ministry of Health, the Ministry of Industry, the Laboratoire Central des Industries Electriques (LCIE) and LNE. It is responsible for medical device approval procedures in France and for developing the implementation of European directives regarding medical devices.
With European directives coming fully into force, the G-MED Economic Interest Group restructures with two partners (LCIE and LNE).
An LNE/G-MED satellite office is set up in Saint-Etienne to have a presence closer to the medical devices industry in southeast France.
All activities of the G-MED Economic Interest Group that were performed by LCIE are absorbed by LNE.
The Economic Interest Group is dissolved. LNE becomes the sole certification body and notified body. The G-MED brand is retained.
The GMED North America subsidiary is set up in Washington, DC (USA).
GMED SAS is founded: As of August 1, GMED becomes a wholly-owned subsidiary of LNE in the form of a simplified joint-stock company (SAS).
GMED designated as Notified Body under European Regulation on medical devices.
GMED SAS (France) is recognized as a Training Organization.
GMED designated as Notified Body under European Regulation on in vitro diagnostic medical devices.
Under the guidance of its board and president, GMED’s leadership team is built with managers, all with robust knowledge of the health care environment and its challenges.
As a service provider for voluntary and regulatory medical certification, GMED supports you in your certification projects to market your medical devices around the world.