ISO 13485:2016 training (2 days)

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ISO 13485 training

From an internal auditor perspective, you will learn about the scope, use and clauses of ISO 13485. Get to know the basics of auditing, the different types of auditing, the techniques for interviewing and assessing processes and how to prepare and perform an internal audit including the communication of the results in a report.



Program overview

Program overview:

an Introduction to EU Medical Device Regulations

Key changes w.r.t. ISO 13485:2003

Handling process approach and risk-based approach

Reviewing the details of the ISO 13485:2016 requirements

Transitions and Timelines

Explaining approaches to update the QMS

Questionnaire and answers

Learning Objectives

  • Understanding the purpose of MMD/MDR and ISO 13485:2016 and the relationship between them
  • Understand the "process approach" and the "risk-based approach"
  • Identify QMS documentation requirements and management responsibilities
  • Understand resource management requirements, product realization requirements and "improvement processes"

Who should attend

If you are in Senior management, Quality Assurance Managers, Internal auditors and anyone involved in the implementation and maintenance of a Quality Management Systems in the Medical Device Industry.




We offer open enrolment, on-location, train-the-trainer formats.

For more details, contact us.

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