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On March 13th, 2019 the Council of the European Union released two corrigenda documents, pertaining to the Regulation (EU) 2017/745 on Medical Devices and the (EU) 2017/746 on In Vitro Diagnostics Medical Devices. In an effort to rectify mistakes and discrepancies within the new European...
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...
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,...
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.
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...
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