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Training course designed and delivered by our expert dedicated to the Transition to the new ISO 13485:2016 Standard

Pick one date: February 14th or February 15th.

Location:

Soka University of America
Small Conference Center
One University Drive
Aliso Viejo, CA 92656

NEW Training ISO 13485 2016

With over one million certified companies over the world, the international quality management systems standard ISO 13485 is among the most commonly used today.

Since the first publication in 1993, several revisions have taken place aligning those standards to the evolution of the market needs. The latest edition of ISO 13485 standard for the medical device industry was officially published February 25th, 2016.

Manufacturers have yet to understand the changes involved to undertake a smooth transition of their QMS and maintain compliance. 

Objectives of the training

  • Understand the new concepts and definitions introduced by ISO 13485:2016
  • Comprehend the new regulatory requirements and purpose for ISO 13485:2016
  • Cross referencing between the old and new versions for a smooth transition

PROGRAM

8:30 am to 9:00 am - Breakfast

9:00 am - 12:15 pm

  • The regulatory context surrounding the revision of ISO 13485
  • The areas of increased emphasis
  • Additions, key requirements and evolutions:
  • Introduction, scope and role,
    • Clause 3: Definitions
    • Clause 4: General requirements introduced by the 2016 version
    • Clause 5: Management Responsibility
    • Clause 6: Resource Management
    • Clause 7: Product Realization
    • Clause 8: Measurement, Analysis and Improvement

1 pm - 5:00 pm

  • Workshop session
  • Transition planning

What is included?

  • Copies of the training material will be provided to each attendee.
  • Attendees will receive a certificate of attendance from LNE/G-MED. 
  • Training method: Includes presentation, slides and exercises 
  • Breakfast, Lunch and Refreshments
About the trainer
Florianne Torset Bonfillou LNE Gmed

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.

 

Register Today!

 

lne gmed arrow February 14th, Tuesday

 
 

lne gmed arrow February 15th, Wednesday

 

Follow the links above to register on February 14th or 15th, if you have any further questions please don't hesitate to contact us.

MDSAP Prepare the transition, worldwide market access

combo ISO 13485 9001

Questions?

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

lne gmed arrow Submit a request

clientsWe're Hiring!

Due to rapid growth in North America, we're seeking Lead Auditors and Certification Project Managers responsible for medical device manufacturing clients.

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