Overview

Medical device companies face growing pressure to comply with multiple regulatory systems across different countries. The Medical Device Single Audit Program (MDSAP) streamlines this process by allowing one audit to satisfy the requirements of participating markets, including the U.S., Canada, Japan, Brazil, and Australia. But to fully benefit from MDSAP, organizations need qualified internal auditors who can apply the model effectively and drive meaningful quality improvements. That’s where this training comes in.

This training course is certified by Exemplar Global and gives you the tools and skills to audit Quality Management Systems in alignment with MDSAP and ISO 13485. Taught live-online over three days, this interactive course is designed for professionals at all experience levels.

Through practical exercises and real-world case studies, you’ll learn to conduct effective audits using the audit model. You’ll follow the complete audit process, from planning and preparation to closing meetings and reporting, while developing the confidence to interpret and apply requirements in real audit scenarios.

Rather than focusing on theory, this course emphasizes hands-on learning. You’ll gain practical techniques for conducting interviews, identifying audit evidence, and uncovering opportunities for true quality system improvement.

Whether you’re responsible for audits, preparing for MDSAP certification, or supporting your organization’s compliance efforts, this course equips you to perform internal audits that add value.

Prerequisites

There are no required prerequisites for this training, though familiarity with ISO, US, Australia, Brazil, Canada, and Japan quality system requirements for medical devices is helpful.

This MDSAP training is beneficial for both quality novices and lifetime professionals. Our goal is to meet everyone at their current level of competence and improve it.

All students are required to bring their own printed copy of the ISO 13485:2016 standard.

This will not be provided by Axeon, but most students will be able to obtain a copy from their company.

Who Should Attend

• Quality Managers
• Audit Program Managers
• Internal and external auditors
• Management Representatives
• Project Teams
• Individuals assisting their organizations toward ISO 13485 registration

This MDSAP training course is certified by Exemplar Global, and upon completion, participants will receive a certificate that says they have successfully completed a course certified by Exemplar Global.