ISO 13485:2016 Medical Devices Quality Management Implementation Training Course

Course Aim: Develop your knowledge and skills in the process of implementing ISO 13485:2016 within an organization that provides medical devices or services to support medical devices.

Course Description: You’ll be introduced to the concepts needed to understand, develop and implement a Quality Management System (QMS). This course provides the knowledge and process steps to enable the effective implementation of a QMS that is in line with the requirements for ISO 13485:2016 certification.

How will you benefit?

This course will help you:

  • Understand how to implement a QMS as required by medical device directives
  • Plan the implementation of ISO 13485:2016 within your organization
  • Take the first steps towards ISO 13485:2016 certification
  • Identify how you can better meet regulatory requirements
  • Find ways to increase efficiency and add value through quality management
  • Monitor supply chains to achieve continuous improvement

Prerequisites

You should have a good knowledge of ISO I3485:2016 and the key principles of a QMS. If not, we strongly recommend you attend our ISO 13485:2016 Introduction course.