Lead Auditor Training Based on the International MDSAP Audit Approach

Course Duration: 5 Days - 8 Hours/day

This five-day training course covers the requirements of the international Medical Device Single Audit Program (MDSAP) Audit Approach, as well as the methods to audit the regulations for conformity and the requirements for Auditing Organizations. This course is intended for those who plan to become a third-party MDSAP auditor, or those serving as lead auditors of their internal audit teams.

Medical device auditing requires technical knowledge as well as a deep understanding of international medical device regulations. This course is designed for those that are already experienced and have been trained on ISO 13485. While the linkages to ISO 13485 requirements will be discussed, the 13485 requirements are not covered in depth. This is in line with IMDRF competency and training requirements, which require:

  • 40 hours of training in quality management systems (e.g., ISO 9001) including a minimum of 8 hours dedicated to additional medical device quality management system requirements (e.g., ISO 13485)
  • 32 hours of training in medical device regulations and auditing for conformity to these regulations
  • 8 hours training in risk management principles, preferably related to the design of a medical device (e.g., ISO 14971)

Note: Omnex offers further training on both ISO 13485 and ISO 14971. For third-party auditors, check with your Auditing Organization for specific training requirements.

This 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, as well as to plan, conduct, report and follow-up on QMS audits in accordance MDSAP. Auditing standards include MDSAP requirements, ISO 19011 and ISO 17021 (MDSAP auditors need to follow ISO 17021).

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

This course will help you:

  • Improve auditing skills focused on regulatory auditing
  • Improve competence for MDSAP development, implementation and maintenance of a QMS that meet all MDSAP audit requirements
  • Assess your own audit models and suggest improvement
  • Be prepared to support an efficient MDSAP audit by your selected Auditing Organization
  • Be eligible to become an MDSAP external AO auditor

Learning Objectives

Participants will gain the knowledge and skills to:

  • Describe MDSAP Background and Acceptability
  • Describe MD-QMS documentation and MDSAP structure
  • Determine and audit requirements for Device Marketing
  • Define and audit Measurement, Analysis and Improvement processes
  • Define and audit Medical Device Adverse Event & Advisory Notices Requirements (AEANR)
  • Define and audit MDSAP Design & Development processes
  • Define and audit MDSAP Production and Service Control processes
  • Define and audit MDSAP Purchasing process
  • Audit MDSAP tasks and various compliance requirements
  • Plan and conduct an audit using the MDSAP approach
  • Define MDSAP reporting and nonconformity grading methods
  • Meet the requirements of Auditing Organizations in a MDSAP audit
  • Conduct a MDSAP certification audit and complete the post-audit activities including the RAIE process.

Course Outline

Day One

  • Introduction and Welcome
  • MDSAP Background & Acceptability and MDQMS Structure

o Exercise 1: GHTF SG3 Risk Assessment

  • Chapter 1: Management Processes
  • Chapter 2: Device Marketing Processes

o Exercise 2: Audit Scenarios – Management Process and DMAFR

  • Chapter 3: Measurement, Analysis and Improvement (MAI) Processes
  • Chapter 4: Adverse Event & Advisory Notices Requirements (AEANR) Processes

o Exercise 3: Audit Scenarios – Measurement, Analysis and Improvement and AEANR

Day Two

  • Chapter 5: Design & Development Processes

o Exercise 4: Audit Scenarios – Design & Development

  • Chapter 6: Production and Service Controls
  • Chapter 7: Purchasing Process

o Exercise 5: Production and Service Control and Purchasing

  • Understanding MDSAP Audit Model Final Exam

Day Three

  • Chapter 8: Planning an Audit using the MDSAP Approach
  • Chapter 9: Preparing for a MDSAP Audit

o Auditing Breakout Exercise 1: Audit Objectives and Scope

o Auditing Breakout Exercise 2: Calculating Audit Duration

o Auditing Breakout Exercise 3: Preparing an Audit Plan

Day Four

  • Chapter 10: Conducting an Audit using the MDSAP Approach
  • Chapter 11: Raising Nonconformities and Closing Meeting

o Auditing Breakout Exercise 4: Raising and Grading Nonconformities

  • MDSAP Auditing Final Exam

Day Five

  • Chapter 12: Auditing Organizations and the MDSAP Audit
  • Chapter 13: Managing Conflict in the MDSAP Audit
  • Chapter 14: Post-Audit Activities of the MDSAP Certification Audit
  • MDSAP Auditing Mock Audit Case Study
  • Leading MDSAP Audit Teams Final Exam

Who Should Attend

The course is designed for medical device professionals with 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 course.

Course Materials

Note: Omnex does not provide copies of standard(s) during training courses, but clients are encouraged to have their own copy.


  • Understanding the Requirements of ISO 13485, or equivalent training, must be completed before attending this course.
  • If you have no previous auditing experience, the full ISO 13485 Internal or Lead Auditor Training is strongly recommended.

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