Training course designed and delivered by our expert dedicated to the Transition to the new ISO 13485:2016 Standard
With over one million certified companies over the world, the international Quality Management System standard ISO 13485 is among the most commonly used.
Since its first publication in 1993, several revisions have taken place aligning the standard with the evolution of the industry and the market needs. The latest edition of ISO 13485 standard for the Medical Device Industry, ISO 13485:2016, was officially published February 25th, 2016.
Medical Device manufactures have yet to understand the changes involved to undertake a smooth transition of their QMS and maintain compliance.
Describe the new concepts and definitions introduced by ISO 13485:2016.
Learn and comprehend the key changes and regulatory requirements introduced in the 2016 version of ISO 13485.
Understand the importance of gap assessment and transition timelines.
Cross referencing between the former versions of ISO 13485 ( ISO 13485:2003 and NF EN ISO 13485:2012) and ISO 13485:2016 for a smooth transition.
9:00 am – 12:15 pm
Transition to ISO 13485:2016
The regulatory context surrounding the revision of ISO 13485
The areas of increased emphasis in ISO 13485:2016 (Risk management, software validation etc.).
The additions, key requirements and evolutions of the ISO 13485 standard:
Clause by Clause review of the changes :
Clause 3: Definitions
Clause 4: General requirements introduced by ISO 13485:2016
Clause 5: Management Responsibility
Clause 6: Resource Management
Clause 7: Product Realization
Clause 8: Measurement, Analysis and Improvement
12:15 pm - 1:00 pm
1:00 pm- 5:00 pm
Workshop and Course Evaluation
Summary and Discussion
Copies of the training material (presentation, slides and exercises)
Certificate of attendance
About the trainer
Florianne Torset-Bonfillou Director of Regulatory, Education and Quality – Lead Auditor at LNE/G-MED North America, Inc. Florianne Torset-Bonfillou is the Director of Regulatory , Education and Quality at LNE/G-MED North America. She received her Bachelor’s Degree in Biology from the University of Burgundy and her Master’s Degree in Chemistry from University of Paris 12. She holds a professional certificate in Quality, Safety and Environmental Management. Prior to joining LNE/G-MED, Florianne worked in the Pharmaceutical and Medical Device industry as a Quality Assurance Project Manager. At LNE/G-MED, Florianne is a Senior Design Dossier Reviewer and Lead auditor. She is also a trainer on the European Regulation, Quality Management, Risk Management, and other regulatory and quality topics.
We serve your passion for progress in the Medical Device (MD) and In Vitro Diagnostics (IVD) industry from the United States
Our Clients Say
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.
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.
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.
Engineering Specialist, Design Control & Risk Management | Device Development
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.