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The ISO 13485 standard represents a Quality Management System base for many regulatory schemes. With the recent publication of the new Medical Device and In Vitro Diagnostic Regulations, the regulatory framework surrounding Medical Devices evolves and re-enforces the control of external parties...
Join us on Wednesday, May 24th at 2:00 PM Eastern as LNE/G-MED North America Inc. will be hosting a free informative session on Control of Critical Suppliers for Medical Devices: ISO 13485:2016 perspectives. Register Now!
The Medical and In Vitro Diagnostic Medical Devices regulations (MDR and IVDR) have been published on May 5th, 2017 in the Official Journal.
The Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR) were initially proposed in 2008 when the EU Commission triggered a consultation on the community’s existing requirements covering medical devices. The plan was 1st released by the commission in 2012 to modify the...
Within the last few years, the Medical Device industry has witnessed a series of changes. The last one took place on April 5th, when the EU Parliament concluded years of tractions and discussions with the vote of the Medical Device and In Vitro Diagnostic Regulations.
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.