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A customizable, cost-effective solution for groups of 5 or more. Contact us to learn more »

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Enroll three students in the same course (held on the same date and at the same location) at the regular price and receive a fourth enrollment for free. *This offer cannot be combined with any other promotional offer(s).


Transition to the Medical Device Single Audit Program (MDSAP)

Health Canada will require MDSAP certification by January 2019 - if you sell in Canada, make sure you plan ahead.

The Medical Device Single Audit Program (MDSAP) allows medical device manufacturers to streamline regulatory compliance for five separate markets with a single audit. Currently, Australia, Brazil, Canada, Japan, and the United States are participating in the program – with Health Canada requiring MDSAP certification by January 2019.

The MDSAP approach will allow for greater consistency, predictability, and transparency of regulatory approaches, and minimize the regulatory burden on industry. The MDSAP also provides an opportunity for manufacturers to bring their quality management systems up to a new level that fully recognizes the interrelationship of processes and the application of risk-based thinking.

Manufacturers need to evaluate the benefits and challenges of participating in the program and plan accordingly. Our 2-day course will help you get started. It covers the elements of the MDSAP, what is included in an MDSAP audit, and how to prepare for MDSAP participation.

Highlighted Handouts:

  • MDSAP Audit Checklist
  • MDSAP Organizational Readiness Tool
  • MDSAP Audit Tasks by Additional Country-Specific Requirements: An Analysis
  • MDSAP Audit Tasks by Process: An Analysis
  • Quality Plan Template: Prepare for MDSAP Participation

Upcoming Dates and Locations

Please Contact Us if you need additional information or if you don't see a date that works for you. To register by phone, call 1.888.532.6360  |  On-Site training available, learn more »

Location Start Date Days Cost Public Course On-Site
Chicago, IL 08/23/2017 2 $1995.00 Add to Cart CONTACT US
Boston, MA 08/30/2017 2 $1995.00 Add to Cart CONTACT US
Orlando, FL 09/13/2017 2 $1995.00 Add to Cart CONTACT US
San Diego, CA 09/20/2017 2 $1995.00 Add to Cart CONTACT US
Minneapolis, MN 09/27/2017 2 $1995.00 Add to Cart CONTACT US
Indianapolis, IN 10/04/2017 2 $1995.00 Add to Cart CONTACT US
Edison, NJ 10/10/2017 2 $1995.00 Add to Cart CONTACT US
Chicago, IL 10/16/2017 2 $1995.00 Add to Cart CONTACT US
Irvine, CA 10/25/2017 2 $1995.00 Add to Cart CONTACT US
San Jose, Costa Rica 10/30/2017 2 $1995.00 Add to Cart CONTACT US
Boston, MA 11/15/2017 2 $1995.00 Add to Cart CONTACT US
Raleigh, NC 11/29/2017 2 $1995.00 Add to Cart CONTACT US
San Francisco Area, CA 12/06/2017 2 $1995.00 Add to Cart CONTACT US
Austin, TX 12/13/2017 2 $1995.00 Add to Cart CONTACT US

Course Objectives

  • Present an overview of the MDSAP, including roles and responsibilities, and benefits and challenges.
  • Assess organizational readiness for successful participation in the program.
  • Practice the process-based approach using the MDSAP audit model, including outcomes, process, tasks, and process linkages.
  • Explain how MDSAP auditors use the nonconformity grading matrix.
  • Identify the necessary MDSAP preparation steps, including activities related to a gap assessment, the internal audit team, and planning for MDSAP participation.

Course Topics

  • MDSAP and its elements
  • Processes and the process-based approach to auditing
  • MDSAP core processes, linkages, risk elements, and country-specific deviations
  • The nonconformity grading matrix
  • Organizational readiness and aligning the internal audit program to the MDSAP approach

Who Should Attend

This course is designed for anyone from the medical device industry with responsibility for one or more elements of an organization’s quality management system, including staff and top management in regulatory compliance, QA/QC, and internal auditing.

Number of Days: 2
CEUs: 1.5
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Bring any of our classes to your location - Oriel STAT A MATRIX on-site training is the perfect solution for training groups of five or more employees or launching a companywide training effort. It's cost-effective, completely customizable, and absolutely hassle-free. For more information, call 1.888.532.6360 or Contact Us.

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