This unique training brings the most forward-thinking
discussions on ISO 13485:2016 and MDSAP to an intimate
gathering of RA/QA professionals, medical devices manufacturers
and professionals working in the medical devices area.
1) Click on this link 2) Select the applicable ticket 3) Enter the promo code GMED15
About the trainer:
Florianne Torset-Bonfillou, Senior Design Dossier Reviewer, Lead Auditor and Director of Regulatory, Education and Quality at LNE/G-MED North America, Inc will lead the training session and discuss the changes and regulatory requirements of ISO 13485:2016 and the fundamentals of the MDSAP (Medical Device Single Audit Program).
"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."