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Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program

 Certified TPECS Provider for the QM-MDSAP Competency Unit 

Oriel STAT A MATRIX is the first provider of Exemplar Global’s QM-MDSAP Competency Unit.

Upon completion of this class, participants are prepared to earn an exam-based certificate that can be used as independent evidence of your training and qualification to maintain MDSAP compliance!

Designed for experienced auditors, course participants learn how to apply MDSAP's process-based approach and align your current internal audit program to the MDSAP requirements. We also take a detailed look at country-specific requirements for the five MDSAP participant markets: Australia, Brazil, Canada, Japan, and the United States.

Which MDSAP training is right for you?

Do you need to learn how to perform internal audits to MDSAP requirements?

Then this class is right for you.  

Is your organization preparing for MDSAP (or thinking about MDSAP)?

Choose our Medical Device Single Audit Program Training. It covers the elements of MDSAP, what is included in an MDSAP audit, the use of the nonconformity grading matrix, and how to prepare for MDSAP participation.

New to auditing?

Consider our Lead Auditor Training for ISO 13485.

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
Boston, MA 04/02/2019 4 $2995.00 Add to Cart CONTACT US
Indianapolis, IN 04/30/2019 4 $2995.00 Add to Cart CONTACT US
Minneapolis, MN 05/07/2019 4 $2995.00 Add to Cart CONTACT US
San Francisco Area, CA 05/14/2019 4 $2995.00 Add to Cart CONTACT US
Edison, NJ 06/04/2019 4 $2995.00 Add to Cart CONTACT US
Orlando, FL 06/18/2019 4 $2995.00 Add to Cart CONTACT US
Chicago, IL 07/09/2019 4 $2995.00 Add to Cart CONTACT US
San Jose, Costa Rica 07/15/2019 4 $2995.00 Add to Cart CONTACT US
Boston, MA 07/30/2019 4 $2995.00 Add to Cart CONTACT US
San Diego, CA 08/13/2019 4 $2995.00 Add to Cart CONTACT US
Raleigh, NC 08/20/2019 4 $2995.00 Add to Cart CONTACT US
Edison, NJ 09/10/2019 4 $2995.00 Add to Cart CONTACT US
San Francisco Area, CA 09/24/2019 4 $2995.00 Add to Cart CONTACT US
Minneapolis, MN 10/08/2019 4 $2995.00 Add to Cart CONTACT US
Orlando, FL 10/22/2019 4 $2995.00 Add to Cart CONTACT US

Learning Objectives

  • Examine MDSAP as a system audit, compliance audit, product audit, and process audit.
  • Identify requirements for auditing technical documentation and sterilization processes.
  • Review MDSAP processes, tasks, outcomes, linkages, and nonconformity grading.
  • Analyze device regulations in MDSAP jurisdictions: Australia, Brazil, Canada, Japan, and the US.
  • Review the intent and guidance for ISO 13485:2016 interpretation.
  • Evaluate objective evidence using a case study approach to simulate an MDSAP internal audit.
  • Apply a risk-based approach to designing the internal audit program.
  • Evaluate strategies for aligning the internal audit program to MDSAP.

Who Should Attend

This is an advanced auditing course and participants are expected to have hands-on experience in medical device internal auditing and a working knowledge of ISO 13485:2016.

Recommended Prerequisite

Oriel STAT A MATRIX courses Lead Auditor Training for ISO 13485  or Internal Auditor Training for ISO 13485, or significant field experience conducting ISO 13485 audits. 

Exemplar Global Certification

This course prepares you to earn an exam-based certificate that can be used as independent evidence of your competency to maintain MDSAP compliance! Oriel STAT A MATRIX is the first and only provider of Exemplar Global’s QM-MDSAP Competency Unit.

Number of Days: 4
CEUs: 2.8
On-Site Training Close

The dates you choose. The location you want.
The results you need!

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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