New ISO 13485:2016, the Medical Device Single Audit Program and Regulatory Transitions

Lincolnshire, Illinois
Tuesday, May 24, 2016
New ISO 13485:2016, the Medical Device Single Audit Program and Regulatory Transitions
Tuesday, May 24, 2016 8:30 AM -
Wednesday, May 25, 2016 5:00 PM (Central Time)

Marriott Lincolnshire Resort
US,HS,MD,CR
847-634-0100
10 Marriott Drive
Lincolnshire, Illinois 60069
United States

Map and Directions

What you will learn

  • Understand the design specifications for the 2016 version of ISO 13485 released March 2016
  • Learn the differences between ISO 13485:2003 and ISO 13485:2016
  • Understand the new regulatory Quality Management System (QMS) audit findings/nonconformance grading system and what grades trigger regulatory follow-up
  • Learn about the Medical Device Single Audit Program (MDSAP) and how Australia’s TGA, Brazil’s ANVISA, Canada’s HC, Japan’s PMDA, and the United States’ FDA will implement the program moving from the pilot to the operational phase in January 2017
  • Learn how the EU Commission, the WHO IVD Prequalification Program and other emerging regulators are participating and utilizing parts of the Single Audit program
  • Understand the new ISO 13485:2016 revision transition for regulatory and certification purposes. Learn about the regulatory transitions for MDSAP and discuss strategies on how companies can optimize alignment

Trainer 

Kimberly A. Trautman, NSF International, Executive Vice President, Medical Device International Services

Kim has been a U.S. International Expert and U.S. TAG Co-chair for ISO Technical Committee 210 Working Group 1, authors of the ISO 13485 standard, since its inception in 1994.  She is also a member of the U.S. TAG for Technical Committee 176, authors of the ISO 9000 series of standards, since 1992.  Kim worked for 25 years at the U.S. FDA in the Center for Devices and Radiological Health where her last position was Associate Director for International Affairs within the Office of the Director.  Over the past four years, she conceived, developed, implemented, and chaired the regulatory Medical Device Single Audit Program internationally.  Currently at NSF International in the Health Sciences Division, Kim is leveraging her over thirty years of medical device sector experience to expand international regulatory affairs and compliance services for NSF International clients.  In addition, she is expanding the current U.S. and European medical device training services internationally, and spearheading the development of an independent third party regulatory certification program.

 


 

Contact Information

Payment Instructions

  • Attendees -    $1800
    Government -  $800

    A hard copy of ISO 13485:2016 will be provided with the course material.
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