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Duration

1-Day

9:00 AM to 5:30 PM EST

   

Course Fee

  • US$795.00 per attendee (for courses held in US)
  • CAD$795.00 per attendee (for courses held in Canada)

   

Certificate

Participants will receive the below certificates at the conclusion of the course. All certificates are issued by TUV USA.

Certificate of Attendance to the attendant who participates in the entire course.

Course Overview

The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. At its inaugural meeting in Singapore in 2012, the IMDRF identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP). The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.

    

Course Objective

This 1-Day MDSAP Overview Course provides detailed information on the MDSAP requirements in order to develop a good understanding of our attendees after the course.

   

Day 1

  • Background and History
  • What is MDSAP?
  • MDSAP: Specific QMS Requirements
  • The similarities and differences among the Quality Management System Requirements in different regions such as Canada, Brazil, Australia and Japan and their relevant regulations
  • How the above relate to ISO 13485:2016?
  • Preparation for MDSAP

   

Pre-requisites

The attendee shall have a basic knowledge of medical device industry.

   

Learning Objectives

Attendees will achieve the following learning outcomes after completing the course: • Understanding what is MDSAP

  • Understanding the Quality Management System Requirements in different regions such as Canada, Brazil, Australia and Japan and the relevant regulations
  • Understanding the relationship of the above to ISO 13485:2016
  • Understanding what shall be prepared for MDSAP

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Katie Lehoullier


Katie Lehoullier joined the TUV USA team in 2016 as Administrative Office Support. Katie assists in the development of TUV USA’s Academy Division as the Training Coordinator.