This one day course provides you with a full understanding of the requirements ISO13485:2016 place on your Quality Management System, as well as the solutions recommended in the 13485 Handbook.
After this course you will be equipped to tackle the questions above. We’ll walk you through the key ISO13485:2016 requirements on the Medical Device quality management systems and provide you with tools to perform an efficient audit of your quality system, or to review and improve your own quality system.
In this course you will learn how to
Completion of this course will give you the knowledge needed to assess or audit the quality management system of your own organisations, or 3rd party (like suppliers, against all aspects of IO13485:2016.
The course is suitable for persons who need to implement, maintain or audit a Medical Device Quality Management System that need to demonstrate compliance towards ISO13485:2016.
This course is available as an In-House Training course. Let us know if you wish to customize a course or if you are a large group with the same requirements.
Leading specialist with long experience of training are guiding you through regulations, guidelines, interpretations, requirements and applications.
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