Lead Auditor Training Based on ISO 13485:2016 and International MDSAP Audit Model, Exemplar Global Certified

Course Description
Medical device auditing requires technical knowledge as well as a deep understanding of international medical device regulations. This five-day training course is focused on international MDSAP and ISO 13485 compliant medical device requirements and auditing methods. Course participants will gain knowledge and skills to conduct audits of ISO 13485:2016 management system requirements in accordance with the new MDSAP Audit Model.

The course provides extensive practical training and hands-on exercises that will help prepare medical device auditors to identify critical nonconformities and meet international regulatory requirements. During training participants will learn to plan, conduct, report, and follow up on QMS audits in accordance with ISO 13485:2016 and MDSAP. Auditing standards include MDSAP requirements, ISO 19011, and ISO 17021 (MDSAP auditors need to follow ISO 17021). 

Who Should Attend
The course is designed for medical device professionals responsible for conducting or implementing internal audits, supplier audits, or corporate audits. Quality directors, regulatory managers, and professionals responsible for managing internal, corporate, supply chain or certification responsibilities may also benefit.

Learning Objectives
Through training, participants will learn to:

  • Improve auditing skills focused on regulatory auditing
  • Assess your audit models and suggest improvement
  • Support an efficient MDSAP audit by your selected Auditing Organization
  • Demonstrate awareness of MDSAP fundamentals
  • Explain the structure and scope of the MDSAP audit
  • Maintain MDSAP and organizational regulatory compliance
  • Understand MDSAP reporting and nonconformity grading methods
  • Explain the differences between MDSAP and other QMS audits such as ISO 13485:2016
  • Determine MDSAP documentation requirements
  • Prepare to host a successful MDSAP audit
  • Audit seven MDSAP auditing process requirements
  • Plan, conduct and lead MDSAP audits
  • Analyze data sources and control interactions required during process audits
  • Use correct jurisdictional terminology
  • Understanding auditing to ISO 19011 and ISO 17021 requirements

Course Outline
Day One
Introduction and Welcome
Chapter 1: MDSAP Background
Chapter 2: MDSAP Audit Structure
Chapter 3: Quality Management System
Written Exercise 1: Risk Management
Chapter 4: MDSAP Audit Model and Tasks
Management Processes
Device Marketing Authorization and Facility Registration
Measurement, Analysis and Improvement
Written Exercise 2a: Audit Scenarios

Day Two
Chapter 4: MDSAP Audit Model and Tasks (cont’d)
Medical Device Adverse Events & Advisory Notices Reporting
Design and Development
Production and Service Controls
Written Exercise 2b: Audit Scenarios
Understanding MDSAP Final Exam

Day Three
Chapter 5: Auditing using MDSAP Audit Model
Chapter 6: Audit Planning and Preparation
Breakout Exercise 1: Calculating Audit Duration
Breakout Exercise 2: Audit Objectives and Scope
Breakout Exercise 3: Preparing an Audit Plan
Breakout Exercise 4: Documentation Review

Day Four
Chapter 7: Audit Checklists
Chapter 8: Performing the MDSAP Audit
Chapter 9: Raising and Grading Nonconformities
Breakout Exercise 5: Raising and Grading Nonconformities

Day Five
Chapter 10: Leading Audit Teams
Chapter 11: Closing the Audit
Conduct MDSAP Mock Audit
MDSAP Lead Auditor Final Exam

Understanding of ISO 13485:2016 with experience in auditing ISO 13485:2016 QMS

Course Format
40 hours
Available virtually

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