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LNE/G-MED North America, Inc.

Notified body established in France since 1901. We serve the medical device industry worldwide with offices on the East and West Coasts of the United States. LNE/GMED is one of the Leading European Notified Bodies in North America and a single-source provider of Voluntary and Regulatory certifications.

notified body in the us, ce mark, iso 13485, mdsap, testing

We provide the best in product certification and quality management certification services for manufacturers. In addition to our CE marking, ISO 9001, ISO 13485 and MDSAP, LNE/G-MED has a long tradition in providing testing services such as EMC and electrical safety testing for any of the European medical device standards. Our full range of technical conformity services, from diagnostic audits to training, allows the convenience and efficiency of a US-based team of technical Experts, Auditors and Program Managers.

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