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

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

Internal 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: 4 Days - 8 Hours/day

OMNEX is now offering QMS Internal Auditor training based on both ISO 13485:2016 and the international Medical Device SingleAudit Program (MDSAP). The four-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.

Learning Objectives

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

Participants will gain the knowledge and skills to:

  • Comprehend MDSAP Background and Acceptability
  • Comprehend MD-QMS documentation and MDSAP structure
  • Audit MDSAP tasks and various compliance requirements in Management processes
  • Determine requirements for device marketing
  • Comprehend Measurement, Analysis, and Improvement processes
  • Determine Medical Device Adverse Event & Advisory Notices Requirements (AEANR)
  • Comprehend MDSAP Design & Development processes
  • Comprehend MDSAP Production and Service Control processes
  • Comprehend the MDSAP Purchasing process
  • Plan for an audit using the MDSAP approach
  • Conduct an audit using the MDSAP approach
  • Understand MDSAP reporting and nonconformity grading methods
  • Explain the differences between MDSAP and other QMS audits such as ISO 13485:2016

Day One

  • Introduction and Welcome
  • MDSAP Background and Acceptability
  • Written Exercise 1: Risk Assessment
  • Chapter 1: Management Processes
  • Chapter 2: Device Marketing Processes
  • Written 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
  • Written Exercise 3: Audit Scenarios – Measurement, Analysis and Improvement and AEANR

Day Two

  • Chapter 5: Design & Development Processes
  • Written Exercise 4: Audit Scenarios – Design & Development
  • Chapter 6: Production and Service Controls
  • Chapter 7: Purchasing Process
  • Written Exercise 5: Production and Service Control and Purchasing
  • Understanding MDSAP Audit Model Final Exam

Day Three

  • Chapter 8: Planning for the MDSAP Audit
  • 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 8: Planning for the MDSAP Audit (cont’d)
  • Chapter 9: Conduct an Audit Using the MDSAP Approach
  • Breakout Exercise 5: Raising and Grading Nonconformities
  • MDSAP Auditing 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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