ISO 13485:2016, MDSAP Requirements and Regulatory Transitions

Orlando, Florida
Monday, March 12, 2018
ISO 13485:2016, MDSAP Requirements and Regulatory Transitions
Monday, March 12, 2018 8:30 AM -
Tuesday, March 13, 2018 5:30 PM (Eastern Time)

Renaissance Orlando at SeaWorld
6677 Sea Harbor Drive
Orlando, Florida 32821
United States

Map and Directions

Course Description

ISO 13485 is the international standard that defines quality management system requirements for organizations involved in one or more stages of the medical device product lifecycle. This includes design and development, production, storage and distribution, installation or servicing of a medical device. ISO 13485:2016 can also be used by suppliers or external parties that provide product and quality management system-related services.

The Medical Device Single Audit Program (MDSAP) audit process was designed to provide a single audit that covers regulatory requirements of medical devices – quality management systems and regulatory purposes (ISO 13485), as well as the specific requirements of medical device regulatory authorities participating in the MDSAP (Australia, Brazil, Canada, Japan, and the US Quality System Regulation).

This course offers practical instruction on both ISO 13485:2016 and MDSAP, preparing you and your organization for the challenges of implanting these requirements and preparing for successful audit outcomes associated with these standards and policies.

Learning Outcomes

By the end of the course you will be able to:

  • Understand the design specifications for the 2016 version of ISO 13485 released in March 2016
  • Learn the differences between ISO 13485:2003 and ISO 13485:2016  
  • Understand the new regulatory Quality Management System (QMS) audit findings/non-conformance 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
  • 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 ISO 13485:2016 revision transition for regulatory and certification purposes
  • Learn about the regulatory transitions form MDSAP and discuss strategies on how companies can optimize alignment

Instructor Information:

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

James Kim Trautman has over 30 years of experience in medical device quality systems and international regulatory affairs. Her vast experience includes leading international initiatives for the U.S. FDA, authoring the current U.S. FDA Medical Device Quality System (QS) regulation, and leading the implementation, rollout and training associated with that regulation. Ms. Trautman is a globally recognized leader of continuing harmonization efforts for ISO 13485 since its conception in 1994.  In addition, she championed the Medical Device Single Audit Program (MDSAP) and led US efforts to develop policies and processes to implement the Program.

Location: Orlando, FL (Exact location TBD)

Cancellation Policy

Cancellations will be accepted up to 30 days prior to the training course, subject to a 10% cancellation fee. Student substitutions will be accepted until the course start date.


Contact Information

Payment Instructions

  • Registration Cost:

    • Individual Registrant- $1,400.00 USD
    • Multiple Company Registrants- 10% discount for three (3) or more registrants

    Registration Fee Includes:

    • All Training Materials
    • Resource Material
    • Lunch daily

    Payment Methods:

    • Major credit card
    • Invoice
      • Please note: payment in full will be needed 7 business days prior to the start of the course if paying via invoice
      • If paying via invoice, all "bill to" information must be filled out. 
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