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 |
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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
- 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
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| Day 1 : The transition to ISO 13485:2016 |
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| 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
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| 12:15 pm - 1:00 pm |
Lunch |
| 1:00 pm- 5:00 pm |
Practice session
- Workshop and Course Evaluation
- Summary and Discussion
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| Day 2 : The fundamentals of the Medical Device Single Audit Program (MDSAP) for Medical Device Manufacturers |
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| 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
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| 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 certified companies
- Q&A session
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| Training materials |
- Copies of the training material (presentation, slides and exercises)
- Certificate of attendance
- Breakfast, Lunch and Refreshments
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| About the trainer |
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Florianne Torset-Bonfillou
Director of Regulatory, Education and Quality – Lead Auditor
Florianne Torset-Bonfillou is the Director of Regulatory , Education and Quality at GMED 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 GMED NA, Florianne worked in the Pharmaceutical and Medical Device industry as a Quality Assurance Project Manager. At GMED NA, 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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