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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).

New! 

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.

“Course workshops that allowed me to practice using MDSAP’s unique process-based audit model were invaluable.” – VP Quality

The Medical Device Single Audit Program (MDSAP) allows medical device manufacturers to consolidate compliance audits from five separate markets or Regulatory Authorities (RAs) 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.  

Our 2-day course provides a solid understanding of the MDSAP program, what to expect during an MDSAP audit, and the key regulatory requirements for MDSAP-participating countries. Through interactive workshops and exercises, participants apply the MDSAP process-based audit approach– including the scoring system that Auditing Organizations (AOs) will use during certification audits. Participants in this class gain additional insight from case studies that share best practices and include practical examples gathered from our customers who have successfully passed their MDSAP certification audits.

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
  • The MDSAP Nonconformity Grading Tool
  • 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
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
San Diego, CA 01/10/2018 2 $1995.00 Add to Cart CONTACT US
Chicago, IL 01/17/2018 2 $1995.00 Add to Cart CONTACT US
Edison, NJ 01/24/2018 2 $1995.00 Add to Cart CONTACT US
Irvine, CA 01/31/2018 2 $1995.00 Add to Cart CONTACT US
Indianapolis, IN 02/07/2018 2 $1995.00 Add to Cart CONTACT US
Austin, TX 02/14/2018 2 $1995.00 Add to Cart CONTACT US
San Jose, Costa Rica 02/21/2018 2 $1995.00 Add to Cart CONTACT US
San Francisco Area, CA 02/28/2018 2 $1995.00 Add to Cart CONTACT US
Orlando, FL 03/07/2018 2 $1995.00 Add to Cart CONTACT US
Boston, MA 03/14/2018 2 $1995.00 Add to Cart CONTACT US
Minneapolis, MN 03/14/2018 2 $1995.00 Add to Cart CONTACT US
Raleigh, NC 03/21/2018 2 $1995.00 Add to Cart CONTACT US

Course Objectives

  • Present an overview of the MDSAP
  • Identify MDSAP roles and responsibilities
  • Assess the benefits and challenges of participating in the MDSAP
  • Describe the MDSAP audit model and how it is used, including objectives, the evidence sought, audit 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 objectives
  • MDSAP roles and responsibilities
  • The MDSAP audit model and audit process
  • The nonconformity grading matrix
  • Preparing for the MDSAP

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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