Introduction to ISO 13485 Medical Devices Training Course

This one day course has been designed to provide an insight into the use of ISO 13485 as the basis for a quality management system implemented by medical device manufacturers. 

Time will be spent during the course reviewing requirements of ISO 13485 and making comparisons to ISO 9001 and the FDA’s Quality System Regulation. In addition to this, participants will also gain an awareness of the relationship between ISO 13485 and ISO 14971, Application of Risk Management to Medical Devices.

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 
  • Develop safe and effective medical devices