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 13485:2016. The course introduces the concepts needed to understand, develop, and implement a quality management system.

How will I benefit?

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