envelope  Contact us

phone1-301-495-0477

lne gmed notified body certification 01

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.

lne gmed notified body testing 02
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.

LNE GMED Notified Body Training Courses 03
Training

A Training Organization with customized courses. Public, online our at your site, our Experts use practical examples in a dynamic and interactive atmosphere.

Check our Training List: ISO 9001:2015 and ISO 13485:2016 Transition, Sterilization Process, Software Lifecycle Processes, etc.

lne gmed notified body training 04
Library

Get the latest news on EU directives, Quality Standards and other important Regulatory Developments, along with practical Guidance for Compliance.

News, Technical Guides, Newsletter and Webinars.

Our services

Latest News

The Medical Device and In Vitro Diagnostic Regulations (MDR and IVDR): Changes and Impacts

  • April 18 - 2017

The Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR) were initially proposed in 2008 when the EU Commission triggered a consultation on the community’s existing requirements covering medical devices. The plan was 1st released by the commission in 2012 to modify the...

The IMDRF publishes a new guideline on Adverse Event Reporting for Medical Devices

  • April 17 - 2017

Within the last few years, the Medical Device industry has witnessed a series of changes. The last one took place on April 5th, when the EU Parliament concluded years of tractions and discussions with the vote of the Medical Device and In Vitro Diagnostic Regulations.

The new IVDR and MDR adopted by the EU Parliament

  • April 13 - 2017

What began in 2012 at the initiative of the European Commission came to an end during the plenary session of April 5th, 2017, with the adoption by the European Parliament of the new regulations on Medical and In Vitro Diagnostic Medical Devices (MDR and IVDR).   

Free Webinar - Key changes in MD & IVD regulations, transition and impacts for Medical Device manufacturers

  • April 10 - 2017

Join us on Wednesday, April 26th, 2017, 2 PM EDT as LNE/G-MED North America Inc. will be hosting a free informative session on the Medical Device and In Vitro Diagnostic regulations, the common changes and timelines introduced by the regulations, and what impact can manufacturers...

Notification of changes: How, what and when to communicate with your Notified Body

  • March 22 - 2017

The Medical Device Industry has always been one of the most demanding when it comes to satisfying its stakeholders. Satisfying and embracing the needs of multiple actors (market evolution, patient safety, investors, regulators and supply chains) has obligated Legal Manufacturers of medical...

Our Clients Say

Don't have an account yet? Register Now!

Sign in to your account

×

ISO13485 Training

Transition to ISO 13485:2016
1 Day Course

Entrust a top training organization like LNE/G-MED to bring your employees up to speed!

The latest edition of ISO 13485 standard for the Medical Device Industry, ISO 13485:2016, was officially published February 25th, 2016. Medical Device manufactures have yet to understand the changes involved to undertake a smooth transition of their QMS and maintain compliance.

Training Content: Click here!

Register Today!

 Calendar Notified Body 05 09

Silver Spring, MD

 Calendar Notified Body 06 06

Santa Clara, CA