ISO 13485:2016 Medical Devices Awareness/Introduction

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

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

• 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.