Implementing ISO 13485:2016 Medical Devices Training Course

This two-day course has been designed to provide participants with the knowledge and process steps to enable them to effectively implement a quality management system in line with the requirements for ISO 13485:2003. The course introduces the concepts needed to understand, develop, and implement a quality management system. 


Who should attend?

  • Anyone involved in defining, planning, or implementing an ISO 13485 based quality management system 
  • Management representatives 
  • Implementation team members



“While quality has always been our number one priority, we now have a more systematic approach to the way it is managed.”

What will I learn?

On completion of this training, participants will be able to:

  • Define a ISO 13485:2016 QMS
  • Identify the steps for defining, planning, organizing and scheduling necessary activities
  • Implement an effective quality management system
  • Conduct a base line review of an organization’s current position with regard to ISO 13485:2016.

What are the benefits?

  • Understand how to implement a QMS as required by medical device directives
  • Plan the implementation of ISO13485:2016 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


What is included?

  • Training course notes 
  • Lunch 
  • Refreshments
  • Certificate of attendance