Overview

Medical device companies face increasing pressure to comply with multiple regulatory systems worldwide. The Medical Device Single Audit Program MDSAP helps streamline compliance by allowing one audit to meet the requirements of key markets, including the U.S., Canada, Japan, Brazil, and Australia. To take full advantage of MDSAP, organizations need highly skilled lead auditors who can manage audit teams, interpret requirements confidently, and deliver results that drive real quality improvements.

This Exemplar Global–certified training course equips you with the knowledge, skills, and credentials to perform and lead audits of Quality Management Systems against MDSAP and ISO 13485 requirements. Delivered live-online over four days, the course combines expert instruction with interactive learning to prepare professionals to take on the responsibilities of a lead auditor.

Through practical exercises, roleplay, and real-world case studies, you’ll gain hands-on experience in planning, conducting, reporting, and following up on audits. You’ll also develop advanced competencies in leading audit teams, managing communication with auditees, and making sound decisions about nonconformities.

Rather than focusing solely on theory, this course emphasizes applied learning. You’ll practice techniques for conducting interviews, analyzing evidence, grading nonconformities, and writing clear nonconformity statements, all while simulating the full audit process.

Whether you’re preparing for MDSAP certification, leading compliance efforts, or expanding your career as a professional auditor, this training provides the foundation and confidence to perform effective, value-added audits as a certified lead auditor.

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.