ISO 13485:2016 Introduction EN

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.   Course Outcomes   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