Medical Devices Regulations

Medical Devices Regulations from LNE G-MED, Notified Body for Medical Devices

By: LNE G-MED, Notified Body for Medical Devices  06/24/2016
Keywords: Manufacturer, Regulatory, medical devices regulation

LNE was established in France in 1901. We serve the medical device industry worldwide. LNE/G-MED is one of the Leading European Notified Bodies and a single-source provider of Voluntary and Regulatory certifications.

Keywords: Manufacturer, medical devices regulation, Regulatory,

Contact LNE G-MED, Notified Body for Medical Devices

Email

Print this page

Other products and services from LNE G-MED, Notified Body for Medical Devices

ISO for Medical Devices from LNE G-MED, Notified Body for Medical Devices thumbnail
06/24/2016

ISO for Medical Devices

LNE/G-MED is authorized to certify a variety of ISO standards. The International Organization for Standardization (ISO) develops standards that help companies monitor and improve their processes and products, in terms of Quality, Environment, Impact, Safety, Reliability, Efficiency and Interchangeability.


CE marking from LNE G-MED, Notified Body for Medical Devices thumbnail
06/24/2016

CE marking

Gain market access to Europe! Before you can offer your medical products to nations within the European Union (EU) and the European Free Trade Association, you must first satisfy the requirements for CE Marking, a conformity mark that signifies a product has met all criteria of the relevant EU directives, especially in the areas of Safety and Performance.


Training from LNE G-MED, Notified Body for Medical Devices thumbnail
06/24/2016

Training

LNE/G-MED America offers a variety of training courses focused on regulatory and quality in the manufacture of medical devices. Our goal is to provide clear, practical "take-home” value to deliver practical impact at your company right away. All of our trainings feature limited class size (10 - 20 attendees) to ensure a high level of interaction, with practical, hands-on practical case studies to encourage material retention and application.


Testing from LNE G-MED, Notified Body for Medical Devices thumbnail
06/24/2016

Testing

One of Europe’s Largest Testing Facility. Offer a complete range of standardized tests or customize tests for characterization. Electromagnetic Compatibility (EMC), Electrical Safety, CB Scheme, Charpy reference specimens.


Certification from LNE G-MED, Notified Body for Medical Devices thumbnail
06/24/2016

Certification

Product Certification and Quality Management System (QMS) services. A complete certification package to save you the time and costs. CE mark, Active Implantable Medicale Devices, In Vitro Diagnostics, Single Audit Program, ISO 13485, ISO 9001.