ISO 13485:2016 and MDSAP Lead Auditor Training

Learn to lead 13485:2016 and MDSAP audit teams.

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Using a hands-on approach, learn to lead an audit of a 13485 conformant and MDSAP regulatory compliant management system. Understand how the 2016 Version of ISO 3485:2016 links and aligns to regulatory jurisdiction requirements and a risk based approach to auditing.  

The course can fulfill training requirements for Medical Device QMS Requirements,  Internal QMS Auditing, and Lead Assessor QMS.


Topics Covered:

  • Concepts and principles of MDSAP-based Quality Systems
  • ISO-13485: 2016 Standard Requirements
  • Applicable Regulatory Aspects—US, Canada, Australia, Japan and Brazil
  • Internal Quality Audits—alignment of your IQSA to MDSAP
  • Regulatory aspects and recognized guidance
  • Risk based approach to audit

Discuss and Learn:

  • Awareness of QMS Principles and MDSAP
  • Understanding of terms and definitions
  • Requirements of and auditor expectations for compliance to Standards
  • Awareness of roles/responsibilities of an auditor, and assessment team leader
  • Different types of audits and purpose
  • Scope, objectives, audit criteria
  • Phases of audit and deliverables, per ISO-19011: 2018
  • Objective Evidence – types of and verification aspects
  • Auditing device technical documentation
  • Writing and Grading a Nonconformity
  • Presenting audit findings and preparing conclusions
  • Communicating during an audit
  • Audit reporting
  • Corrective action follow up and verification
  • Student exercises and activities with role playing
  • Scenarios and case study


  • Regulatory Affairs and QA Professionals
  • Quality Assurance and Compliance Specialists
  • Quality Engineers and Manufacturing Engineers
  • Quality Assurance
  • Management with responsibility for QMS
  • Internal and external auditors of medical device manufacturing/design firms
  • Consultants

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5 Day

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