Training

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

By: LNE G-MED, Notified Body for Medical Devices  06/24/2016
Keywords: Iso 9001, Quality Management System, Iso 14001

A Training Organization with Customized and Online training courses: Validation and Control of the Sterilization Process for Ethylene Oxide & Irradiation Biological Evaluation of Medical devices, Biocompatibility of Materials and Process Medical Device Software Lifecycle Processes Electrical Safety and Electromagnetic Compatibility (EMC) of Medical Devices Requirements of the New IEC 60601-1 (2005) Standard Process Validation for Medical Devices Use a Recognized Method, GHTF Guidelines NF EN ISO 14971 - Risk Management Applied to Medical Devices In Vitro Diagnostic Medical Devices - Technical Documentation Directive 2007/47/EC Revision of the European Medical Device Regulation European Medical Device Regulations Requirements of Directives 93/42/EEC and 90/385/EEC Medical Device Regulation Australia, Canada, Taiwan ISO 14001 - The Environmental Management System Define and Integrate It within Your Quality System

Keywords: Auditor Training, Iso 13485 Training, Iso 14001, Iso 9001, Iso 9001 Training, Iso Training, Quality Management System

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

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

Medical Devices Regulations

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.


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.


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.