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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

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 1.800.472.6477  |  Private training available, learn more »

 
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.

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
In-Person Days: 2
CEUs: 1.5
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Bring any of our classes to your location - Oriel STAT A MATRIX Private 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 1.800.472.6477 or Contact Us.

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