envelope  Contact us

phone1-301-495-0477

Transition to ISO 13485:2016 & MDSAP for Medical Device Manufacturers

Transition to ISO 13485:2016

& The fundamentals of the Medical Device Single Audit Program (MDSAP) for Medical Device Manufacturers

2 days course

Register today!

 

Training MDSAP for Medical Device ManufacturersThis 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

Register today!

LNE/G-MED NA retains the right to cancel the training 7 days before the date if the number of attendees is insufficient.

 

About the trainer
Florianne Torset Bonfillou LNE Gmed

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.

Our Clients Say

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 our rapid growth in North America, we're seeking Lead Auditors, Certification Project Manager Active and Non-Active Medical Device responsible for medical device manufacturing clients.

Training - 2 Days Course

Training EU Medical Device Regulations

 

European Medical Device Regulation 2017/745

Click here to Register


 

Combo Training ISO13485 MDSAP

Transition to ISO 13485:2016

& The fundamentals of the Medical Device Single Audit Program (MDSAP) for Medical Device Manufacturers

Click here to Register

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