Introduction to ISO 13485:2016

This BSI ISO 13485 training is a one-day course for medical device manufacturers. It shows how to use ISO 13485:2016 as the basis for a quality management system (QMS). It also explores the interaction between ISO 9001:2015, the European Medical Device Directive and the US FDA's Quality System Regulation.
 
From consultants to senior managers, this course is suitable for anyone who needs to implement the standard. You’ll learn to use ISO 13485:2016 as the basis for regulatory requirements worldwide and recognize the key clauses.

Choose to take the BSI ISO 13485 training course either in the classroom, live online or on-demand with self-paced eLearning. You’ll find ways to increase efficiency, save costs and develop safe and effective medical devices.

How will I benefit?

  • Understand how to meet regulatory requirements to increase patient safety
  • Monitor supply chains for continuous improvement
  • Take the first steps on your learning journey to ISO 13485:2016 certification
  • Gain an internationally recognized BSI training certificate