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
|8:30 am to 9:00 am
|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
- Breakfast, Lunch and Refreshments
|About the trainer|
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.
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