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Save the date! GMED North America is coming into force at #RAPS2019! September 21-24, 2019 The #2019RAPS Regulatory Convergence Conference is, held at: Pennsylvania Convention Center, 1101 Arch Street, Pennsylvania. PA
In an effort, to mitigate, potential cybersecurity threats due to the increasing levels of interconnectedness and data exchange between medical devices— Health Canada has released a guidance document on “pre-market requirements for medical device cybersecurity.” The guidance document defines...
On June 6th, 2019 the European Union released a document, with a note from the Irish and German Delegations on the implementation of Regulation (EU) 2017/745 on medical devices. The document addresses the increased number of discussions regarding the challenges and concerns facing stakeholders...
The European Union has constructed an excel document detailing essential information regarding the MDR/IVDR implementation rolling plan. The document is organized into two different sections: implementing acts and other actions/initiatives. This document is intended to coexist with the “MDR/IVDR...
The International Medical Device Regulators Forum (IMDRF) held the fifteenth meeting of the Management Committee (MC) in Moscow, Russia on March 18th -21st, 2019. The MC consisted of regulatory leaders from around the world such as: Australia, Brazil, Canada, China, the European Union (EU), Japan,...
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