Awareness Training on Medical Device ISO 13485:2016

Objectives

This course is designed for, all levels of management and those whose responsibility it is to implement new systems or maintain existing systems, for all those involved in advising and auditing quality management systems.

Who the course is for

Familiarity with thestructure and requirements of ISO 9001:2008 is desired. Good working knowledgeof English language is necessary.
Knowledge in MedicalDevice Directives (MDD’s) is desirable but not mandatory.

Course Contents

At the conclusion of this course delegates will have been provided with:

An understanding of the key requirements of ISO - 13485
An understanding of the philosophy behind the standard, and the approaches to quality management
An understanding of the basic ISO 13485:2003 / EN /ISO 13485:2012 concepts
An understanding of the potential benefits of implementation of ISO – 13485 in the Medical Device industry.

Start Date	End date	Information

Coming soon