As a recognized Notified Body and Registrar, LNE/G-MED enables medical device and IVD manufacturers to demonstrate that their quality management systems (QMS) meet international standards, such as CE Marking (all directives and devices), ISO 13485 under CMDCAS, Japan-PAL and FDA Third-Party Inspection.
LNE/G-MED North America gives manufactures access to European, Canadian, Asian and other regulated markets, while offering the convenience and efficiency of a locally-based team of technical experts, auditors and program managers. LNE/G-MED emphasizes responsive, reliable service and offers a full range of training and testing services for continual QMS improvement.
Specialties
medical devices, regulatory certification, CE Marking, ISO 13485 under CMDCAS, FDA 3rd Party Accredidation, training, product and component testing
New hires at LNE/G-MED North America
-
Certification Project Manager
Came from...
bioMerieux, Regulatory Affairs senior manager
