Medical Device Single Audit Program (MDSAP) Training Course

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

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 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.

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.

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.


There are currently no public dates scheduled. All our courses are available to be held at a location of your choice. Please contact us for more information.

In-Person Agenda▸

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 Days: 4
In-Person Days: 2
CEUs: 1.5