This 2 days course explores two of the most recent evolutions in the Medical Device Industry. Both address a desire to harmonize and establish a more global approach to auditing QMS for Medical Device manufactures.
The transition to ISO 13485:2016
The new version of the ISO 13485 standard published in February 25th, 2016 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.
Training content and objectives
ISO 13485:2016
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
Medical Device Single Audit Program (MDSAP)
A brief overview of MDSAP: what countries and regulatory authorities are involved
Introduction of the 5 principles surrounding the Medical Device Single Audit Program (MDSAP) audit for Medical Device Manufacturers
Understand the transition timelines to MDSAP for already CMDCAS certified companies.
The MDSAP finding system and how it differs from a regular QMS audit
The auditing system for MDSAP and how it will impact your organization
Day 1 : The transition to ISO 13485:2016
8:30 am to 9:00 am
Breakfast
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
Lunch
1:00 pm- 5:00 pm
Practice session
Workshop and Course Evaluation
Summary and Discussion
Day 2 : The fundamentals of the Medical Device Single Audit Program (MDSAP) for Medical Device Manufacturers
8:30 am to 9:00 am
Breakfast
9:00 am – 12:15 pm
Concepts and principles introduced by MDSAP
The scope of the MDSAP audit and how it works
MDSAP : The benefits for global organization
MDSAP actors
The MDSAP report
MDSAP documents and forms
12:15 pm - 1:00 pm
Lunch
1:00 pm- 5:30 pm
The MDSAP Audit Cycle
MDSAP Audit Model : a process approach
The Medical Device Manufacturers MDSAP Audit Sequence
Explanation of the grading of non-conformities for MDSAP
The transition timelines to MDSAP for ISO 13485 CMDCAS certified companies
Q&A session
Training materials
Copies of the training material (presentation, slides and exercises)
Certificate of attendance
Breakfast, Lunch and Refreshments
About the trainer
Florianne Torset-Bonfillou Director of Regulatory, Education and Quality – Lead Auditor 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
1-301-495-0477
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.
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.
Sue Powell
Quality Manager
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.
Fady Khalla
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.
This 2 days course explores two of the most recent evolutions in the Medical Device Industry. Both address a desire to harmonize and establish a more global approach to auditing QMS for Medical Device manufactures.
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