Loading ...

Select a program below to learn more or to register.

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

Exemplar Global Certified Certified Internal Auditor Training Course*

This class is available virtually.

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, and review the impact of MDSAP on the affiliate markets: Argentina, Singapore and Republic of Korea.

* 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. 

Read More Courses
Read Less Courses
Course Date Course Detail Virtual Session Details Related Courses

Course Date

Upcoming Dates and Locations

Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times.
Location Start Date Days Cost Public Private
VIRTUAL DELIVERY (Eastern Time) 02/27/2023 5 $3295.00 Add to Cart Contact Us
VIRTUAL DELIVERY (Eastern Time) 05/22/2023 5 $3295.00 Add to Cart Contact Us
VIRTUAL DELIVERY (Eastern Time) 08/21/2023 5 $3295.00 Add to Cart Contact Us
VIRTUAL DELIVERY (Eastern Time) 11/13/2023 5 $3295.00 Add to Cart Contact Us

Course Detail

Learning Objectives

  • 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 of ISO 13485:2016 as well as guidance for interpreting the standard.
  • 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. 

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

    5
  • In-Person Full-Days

    4
  • CEUs

    2.8

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

REQUEST A PROPOSAL Or ask a question!
Get answers right now. Call
1.800.472.6477

© Oriel STAT A MATRIX. All Rights Reserved. Site Map Privacy and Legal