Implementing ISO 13485 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



What will I learn?

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

  • Describe the fundamentals of quality management systems 
  • Explain the purpose, structure and requirements of ISO 13485 
  • Apply a process of implementing a quality management system that meets the requirements of ISO 13485 
  • Prepare for ISO 13485 certification



What are the benefits?

  • Take the first steps towards ISO 13485 certification 
  • Understand how you can better meet customer and regulatory requirements 
  • Find ways to increase efficiency and cost savings through quality management 
  • Monitor supply chains to achieve continuous improvement



What is included?

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