Single Course Medical Devices

MDSAP & Regulatory Requirements - Auditor's Perspective Training Course

2 Days In-person Next: 1 Dec 2026 English Identifier: 183025039

Course Overview

What you'll learn

Course Outline

  • Perform Internal Audits using ISO13485 and applicable Regulations & MDSAP Audit Approach book
  • Review Regulations and Standard against MDSAP Process audit requirements
  • Detail MDSAP 7 auditing process requirements
  • Plan audit
  • Scope
  • Use correct jurisdictional terminology
  • Audit process structure and audit task per Chapter
  • Apply MDSAP nonconformity grading system
  • Write nonconformances using MDSAP reporting and nonconformity grading program
  • Explain differences between MDSAP and other QMS audits

Who This Course Is For

Quality Assurance and Regulatory Affairs professionals responsible for compliance with medical device regulations.

Internal auditors and compliance officers seeking to enhance their auditing skills specific to the MDSAP framework.

Medical device manufacturers and suppliers who aim to streamline their audit processes and meet international standards.

Anyone involved in medical device audits and compliance who wishes to gain a deeper understanding of MDSAP and its regulatory requirements.

About this course

This meticulously designed course aims to provide participants with a robust understanding of the MDSAP framework, which is essential for ensuring compliance with international regulatory requirements.

Join us for an intensive two-day training course that offers a comprehensive deep dive into the Medical Device Single Audit Program (MDSAP) from an auditor’s perspective. This meticulously designed course aims to provide participants with a robust understanding of the MDSAP framework, which is essential for ensuring compliance with international regulatory requirements.

During this course, participants will be guided through the intricate details of the MDSAP program, including its grading system, timing, and reporting procedures. The training will cover the step-by-step audit process sequence, providing insights into each stage of the audit. Special emphasis will be placed on auditing techniques based on ISO 19011:2018, preparing attendees to apply these methodologies effectively in their audit practices.

Participants will also gain a thorough understanding of the various regulations under the MDSAP program, which encompass multiple jurisdictions including the United States, Canada, Brazil, Japan, and Australia. This course will provide an overview of the specific regulatory requirements of each participating country, ensuring that auditors are well-versed in the diverse regulatory landscapes they may encounter.

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