GMED

GMED is a notified body and certification body for medical devices. It assesses device conformity with EU Regulations 2017/745 and 2017/746 and certifies quality management systems under ISO 13485 and the MDSAP program. It also runs regulatory training courses and publishes technical and regulatory content.

Its customers are medical device manufacturers seeking certification to place products on the market, including CE marking, QMS certification and MDSAP audits. The website lists services for certification, training and medical device testing delivered through its parent company LNE.

GMED was known as a G-MED group from 1979 and became a wholly-owned subsidiary of LNE, the French National Metrology and Testing Laboratory, in the form of a SAS on August 1, 2018. Its subsidiaries are GMED North America, based in the Washington, DC area, and GMED Asia, established in Hong Kong. The website states that GMED has 350 people dedicated to certification and an open position for a Product Reviewer IVDR in Paris.

Product: Conformity assessment and certification of medical devices and quality management systems, plus regulatory training courses and technical content.