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

Exemplar Global Certified Certified Internal Auditor Training Course*

Designed especially for experienced auditors, this intensive class will teach you how to apply the process 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. 

* 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. 

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Course Details

What You Will Learn

  • Review MDSAP processes, tasks, outcomes, linkages, and nonconformity grading.
  • Review ISO 13485:2016 intent and guidance.
  • Analyze device regulations in MDSAP jurisdictions.
  • Identify requirements for auditing technical documentation, sterilization processes, and written agreements.
  • Evaluate objective evidence using a case study approach to simulate an internal audit to MDSAP.
  • Apply a risk-based approach to designing the internal audit program.
  • Evaluate strategies and recommendations 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. 

Course Days

Virtual Class Days: 5 days, Mon - Thurs daily 1:00  - 5:00 PM ET; Fri 11:30 - 5:00 PM ET

  • Virtual Half-Days

  • In-Person Full-Days

  • CEUs


Virtual Session Details

Virtual Session Details

Oriel STAT A MATRIX virtual instructor-led training (VILT) is a real-time internet-based learning experience where the instructor and learners are in separate locations. Oriel STAT A MATRIX’s VILT technology platform is designed to simulate a traditional in-person classroom experience and allows for 2-way dialogue, break-out sessions for engaged workshops and hands-on exercises, and group work using virtual breakout rooms. This provides for an engaging learning experience in which participants can connect with the content and interact with both the instructor and other classmates.

The learning objectives and topics covered during VILT are the same as those for the in-person version of the course. To accommodate the VILT format, classes are delivered at a pace well suited to virtual instruction, and the structure of class workshops and exercises has been modified to work best in the virtual environment.

Online Training Schedule

This class is delivered across 5 consecutive days. Monday-Thursday sessions run 1:00-5:00 p.m. ET; the Friday session runs 11:30 a.m.-5:00 p.m. ET to allow time for administering the final exam.

Technical /Logistical Requirements

To participate in this learning, first and foremost, we need your engagement!  You will also need:

  • PC MAC Computer

    PC or MAC Computer

  • Reliable Internet

    Reliable Internet

  • Video Webcam

    Video Webcam

  • Headset or Earbuds

    Headset or Earbuds

  • Quiet Setting

    Quiet Setting

  • Two Monitors Recommended

    Two Monitors

See course dates to find / register for a virtual online session of this course.

Virtual Session Details

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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