This 2 day course explores two of the most recent evolutions in the Medical Device Industry.
Utilized by Regulatory Affairs professionals and Quality Managers over the world, our programs are designed to ensure continual improvement and deliver practical tools.
The transition to ISO 13485:2016
The new version of the ISO 13485 standard introduces new timelines and additional regulatory requirements for companies switching their QMS from ISO 13485:2003 and NF EN ISO 13485:2012.
Medical Device Single Audit Program (MDSAP)
A comprehensive approach to Quality System auditing, which includes the development of an international coalition of countries devoted to pooling resources, technology, and services to enhance the safety and oversight of Medical Devices worldwide.
"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."
Louise Miyamoto, Director, Quality Systems
"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."
Dan Massucco, Vice President of Quality Assurance and Regulatory Affairs
"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."