Sharing a passion for progress

General Info

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. 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.

Hours

Regular Hours

Mon - Fri:	8:30 am - 5:30 pm

Categories

Business Coaches & Consultants, Controls, Control Systems & Regulators-Wholesale & Manufacturers, Management Training, Medical Service Organizations

Services/Products

Certification, CE mark, ISO 13485, ISO 9001, MDSAP, Quality Management System, Testing, CB Scheme, Charpy, Training.

Payment Options

Location

Worldwide presence with offices in the US: - 3930 Knowles Ave. Suite 306, Kensington, MD 20895 - 5701 Lonetree Blvd., Suite 318, Rocklin, CA 95765

Languages

English, French

Associations

European Notified Body (CE 0459) ISO Accredited for various healthcare standards: - ISO 9001 / ISO 13485 Quality Management System - ISO 14001 Environmental Quality System - ISO 15378 Packaging Materials for Medicinal Products Mutual Recognition Agreements / Partnerships: Australia, New Zealand, Taiwan, Japan, Brazil. Accredited Certification Organization by France's accreditation body COFRAC Registrar recognized by Health Canada under the Canadian Medical Devices Conformity Assessment System (CMDCAS) LNE is a Notified, Designated, or Competent Body for the Following Directives: - Directive 90/385/EEC: Active implantable medical devices - Directive 89/106/EEC: Construction products - Directive 89/336/EEC: Electromagnetic compatiblity (EMC) - Directive 98/79/EC: In vitro diagnostic medical devices - Directive 73/23/EEC: Low voltage equipment - Directive 2004/22/EC: Measuring instruments (MID) - Directive 93/42/EEC: Medical devices - Regulation 722/2012/EC Medical devices utilizing tissues of animal origin - Directive 2000/14/EC: Noise (outdoor equipment) - Directive 2009/23/EC: Non-automatic weighing instruments - Directive 94/62/EC: Packaging and packaging waste - Directive 97/23/EC: Pressure equipment - Regulation (EC) 1907/2006: REACH - Directive 88/378/EEC: Toys

Other Link

https://lne-america.com