01Certification
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.
02 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.
03 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.
04 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.
Latest News
The main changes introduced by the “MDSAP AU P0002.005 Audit Approach” document
- September 24 - 2020
On Sept. 3, 2020 the MDSAP consortium has published a new document “MDSAP AU P0002.005 Audit Approach”. This document replaces the former “MDSAP Audit Model” and “MDSAP Companion Document” by a unique combined one. The new MDSAP audit approach document became effective immediately, with a...
GMED designated under Regulation (EU) 2017/745 on medical devices
- July 08 - 2020
GMED (CE 0459) has been designated as a Notified Body under the Regulation (EU) 2017/745 by the French National Agency for Medicines and Health Products Safety (ANSM). Equipped with this designation since July 8th 2020, GMED has mobilized its teams to offer manufacturers with certification...
MDSAP Program Is Now Utilized by 2 Other Countries: South Korea and Argentina
- April 02 - 2020
South Korea (Ministry of Food and Drug Safety) first and now Argentina (ANMAT) have very recently joined the MDSAP program as affiliated members. Although not an observer, like the WHO or the European Union, nor a member of the consortium of regulatory authorities at the initiative of the program...
GMED's Business Continuity Plan in the Context of the COVID-19 Health Crisis
- March 17 - 2020
As the COVID-19 crisis evolves and is now officially a pandemic, we are taking additional security measures to protect our employees, partners, and customers. We have implemented a business continuity plan that ensures the health and safety of our employees, their families and the customers we...
Information Related to the COVID-19 Coronavirus Health Crisis
- March 11 - 2020
GMED implemented exceptional provisions to ensure the protection of its employees, suppliers and customers in the context of the health crisis linked to the coronavirus (COVID-19). A coordination and monitoring unit has been set up at the LNE Group level, including GMED and GMED North...
Our Clients Say
We traveled from Massachusetts to attend the 2days LNE/G-Med ISO 13485:2016 and ISO 9001:2015 transition training and it was well worth the trip. The training was interesting, informative and interactive. The case studies were a great way to try and apply the new aspects of the standards and brainstorm with others. The chance to meet and discuss the new standards with actual LNE auditors was a huge plus.
I just thought you might like to know that we completed our transition audit with only three minor NCs. The auditor was very impressed that we did this on our own without the benefit of a consultant. I give much of the credit to your training class and want you to know that I really think you did an excellent job with the training.
Going into the training I was having concerns about ISO 13485:2016 implementation, but after the training I was amazed by the trainer ability to simplify complicated concepts. I will be happy to go back for additional trainings for different standards.
The workshop was very beneficial for me. It provides training material I can use for my organization. It was good to collect ideas from others in the industry as I complete my gap analyses and begin formulating implementation plan for the changes needed.
Pretty good coverage of the material. Collaborative with group work on examples. The Table of Contents for MDR is a valuable handout. The training was definitely worthwhile.
The examples were excellent as well as working in a team environment with people from various sized organizations. Overall, this training was incredibly positive. The trainer did an excellent job of presenting the information and keeping people engaged.
The trainer was very knowledgeable and open to my many questions. Workshop activities were helpful. I feel more confidence in leading our organization toward the new MDR world.
Great and relevant situational examples of what the trainer has seen based on her experience as it relates to the subject content. Overall, I am very happy I went to the workshop. I feel better equipped to tackle the MDRs
