Lead Auditor Training Based on ISO 13485:2016 and International MDSAP Audit Model

Lead Auditor Training Based on ISO 13485:2016 and International MDSAP Audit Model

Register for courses 60 days in advance and get 10% off this price.

Register for courses 30 days in advance and get 5% off this price

Note:Pricing is dependent on location and may vary.

Course Duration: 5 Days - 8 Hours/day

OMNEX is now offering QMS Lead Auditor training based on both ISO 13485:2016 and the International Medical Device Single Audit Program (MDSAP). The five-day training is focused on international MDSAP and ISO 13485 compliant medical device requirements and auditing methods.

Medical device auditing requires technical knowledge as well as a deep understanding of international medical device regulations. Students participating in this course will gain knowledge and skills to conduct audits of ISO13485: 2016 management system requirements in accordance with the new MDSAP Audit Model.

OMNEX’s Lead Auditor Training course will teach students 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).

Considering the ISO 13485:2016 management system requirements and various regulatory authorities compliance requirements around the world and the global supply chains involved, a comprehensive program like OMNEX’s MDSAP Lead Auditor Training’ is incredibly valuable. The course provides extensive practical training and hands-on exercises, which will help prepare medical device auditors to identify critical nonconformities and meet international regulatory requirements.

The course is designed for medical device professionals with the responsibility 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 from this unique program.

Upon completion, the participants will be capable to audit ISO 13485:2016 and jurisdiction requirements in the countries participating in the MDSAP program.

Participants of the training will learn from highly experienced instructors with decades of experience in medical device quality management systems.

  • Improve auditing skills focused on regulatory auditing
  • Assess your own audit models and suggest improvement
  • Be prepared to support an efficient MDSAP audit by your selected Auditing Organization

Participants will gain the knowledge and skills to:

  • 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

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
  • Purchasing
  • 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

Quality Assurance and Regulatory Affairs professionals within medical device organizations currently active in participating jurisdictions and organizations expanding their market reach to jurisdictions participating in MDSAP.


Thorough understanding of ISO 13485:2016 with experience in auditing ISO 13485:2016 QMS.

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