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Medical Device Single Audit Program (MDSAP) Training: Preparing for a Successful Implementation

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. 

Our 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.

Which MDSAP training is right for you?

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

Then this class is right for you. 

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

Then take our Internal Auditing to MDSAP class. Designed for experienced auditors, participants learn how to apply MDSAP's process-based audit approach and align your current internal audit program to the MDSAP requirements. You will also take a detailed look at country-specific requirements for the five MDSAP participant markets. 

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Course Detail

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.

Highlighted Handouts and Resources

  • 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
  • Virtual Half-Days

  • In-Person Full-Days

  • CEUs


Virtual Session Details

Virtual Session Details

The learning objectives and topics covered during virtual instructor-led training (VILT) are the same as those for the in-person version of the course. As well, all VILT classes are taught by the same experienced team of instructors you’ve come to expect from Oriel STAT A MATRIX. 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. Each virtual session is a combination of subject matter expert and group discussions, interactive whiteboards, polls, and chat rooms that help students with small group exercises, making this an engaging, interactive learning experience.

Online Training Schedule

  • This class is delivered across 4 consecutive business days. Daily 1:00 - 5:00 p.m. Eastern time
  • This convenient half-day format allows you to balance your other responsibilities while still getting the training you need. 

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

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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