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
EMA releases 1st guidance on new rules for certain Medical Devices; it is Article 117 intensive.
- May 14 - 2019
The European Medicines Agency (EMA) plans on publishing a series of guidance documents to assist applicants in the medical device industry in preparation of the obligations delivered by the new Regulation (EU) 2017/745 on medical devices. This guidance document falls within the scope...
Where are Notified Bodies with their application to the EU IVDR 2017/746?
- February 11 - 2019
A recent survey was conducted by Team-NB to determine how notified bodies were approaching the application process for designation under the new EU IVDR 2017/746. The survey report was closed on January 11th, 2019 and reveals that a total of 35 notified bodies responded,...
EU MD (2017/745) and IVD (2017/746) Regulations Pausing to reflect on a Year of Application for Notified Bodies
- January 18 - 2019
November 26th , 2017 saw Notified Bodies able to engage with their designated Competent Authority (CA) to apply for a notification status under the EU MD (2017/745) and/or IVD (2017/746) regulations.
Implementation of the New Medical Device European Regulation (EU) 2017/745 in Non-European Union Member States
- January 16 - 2019
Since its publication, many articles have been published regarding the potential implications of the new European Medical Device Regulation (MDR) on the CE-marked medical devices within the European Union. However this change of regulation goes further than only the European...
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...
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.
