ISO 13485:2016 Introduction Training course

Course Aim: Gain a better insight into the use of ISO 13485:2016 as the basis for a Quality Management System (QMS) implemented by medical device manufacturers.

Course Description: This course explores the requirements of the ISO 13485:2016 Quality Management System standard, discussing key principles and how the standard interacts with ISO 9001:2015, the European Medical Device Directives and US FDA’s Quality System Regulation. The relationship with ISO 14971 ‘Application of Risk Management to Medical Devices’ is also explored during the course.

What will you learn?

On completion, you should gain the knowledge and skills to:

  • Explain the use of ISO 13485:2016 as the basis for a QMS for medical device manufacturers
  • Identify the relationship between ISO 13485:2016 and European Medical Device Directives
  • Recognize the use of ISO 13485:2016 as the basis of regulatory requirements worldwide

Prerequisites

There are no formal prerequisites, however it will be useful for delegates to read the standard before attending the course.