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
ISO 13485:2016 - Ready For the Next Revolution? Time for ISO TC 210 WG1 to Draw Up the Results
- October 30 - 2018
A survey was recently administered by ISO TC210 WG1 to obtain critical information to evaluate the experiences of key stakeholders such as, medical device manufacturers, subcontractors, suppliers, European Authorized Representatives, specialized consulting firms etc., during the ISO 13485:2016...
Free webinar - Stepping into an MDSAP audit
- September 05 - 2018
Join us on Wednesday, September 26th, 2018, 2:00 Eastern Time as GMED North America Inc. will be hosting a free informative session on Stepping into an MDSAP audit. Register Now!
Health Canada to replace the STED by IMDRF ToC format for Class III and IV Premarket Medical Device Licence Applications
- August 29 - 2018
Health Canada published on August 21st, 2018 a notice confirming its “intention to Adopt the Use of the Table of Contents Format for Class III and IV Premarket Medical Device Licence Applications”, a gesture towards the efforts sustained by the IMDRF group to support medical device market...
RAPS 2018 Regulatory Convergence Conference
- August 08 - 2018
Meet our speakers! Vancouver Convention Centre West |Canada| October 1 - 4, 2018 | Booth #415
What does Medical Device Clinical Performance stands for?
- March 26 - 2018
From one Medical Device Manufacturer to another, from one Notified Body to a Medical Device Manufacturer or from one Competent Authority to a Medical Device manufacturer, from Standards to Standards or Regulations, the word “Performance” can be used in a wide different way.
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.
