ISO 13485:2016 Medical Devices Awareness Training Course

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Description

This 1-Day course is designed primarily to provide participants with a detailed understanding of the changes and the effects of the ISO 13485:2016.

 

The key topics include:

  • Introduction to ISO 13485:2016
  • ISO 13485:2016 Overview
  • 1) Section 4: Quality Management System
  • 2) Section 5: Management Responsibilities
  • 3) Section 6: Resources Management
  • 4) Section 7: Product Realization
  • 5) Section 8: Measurement, Analysis and Improvement

 

 

Objectives

Upon successful completion of the course, participants will:

  • To enable participants to understand the requirements of ISO 13485:2016
  • Provide an overview of the new requirements / changes from the ISO 2003/ENISO2012 version to the 2016 version of ISO 13485

Audience

  • Managers, Executives, Supervisors and those who are involved in ISO 13485:2016

  • Personnel who are involved in the implementation and maintenance of the quality management system in accordance to ISO 13485:2016 Standard, or those who wish to know more about the standard and its requirements.

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