Medical Devices Training

Understanding Medical Devices Management Systems - ISO 13485

Course Description

This one day introductory course will give students a broad understanding of the ISO 13485:2003 Quality Management Systems requirements. In addition, the concepts of ISO 14971 - The Medical Device Risk Management Standard - will be introduced. This course is highly interactive with lively debate and in-class discussion, real life examples, and exercises.

Who should attend?

Quality Managers
RA Managers
Auditors of Medical Device manufacturing firms (internal and external)
Executives & Senior Management
Cross functional team members of implementation project

Benefits to Your Business

Delegates are given an understanding of the relevance of various Medical Devices standards to industry in general, and to their own organization in particular.

Course Structure

Understanding proper use of ISO 14969
Understanding differences between ISO 13485:1996 and 2003 version
Interpret all clauses of ISO 13485:2003
Understand the essentials of ISO 14971 - The Medical Device Risk Management Standard
Recognize the role of management in implementing and maintaining ISO 13485

Prerequisite
Knowledge of medical device manufacturing

Further Information

For further information please contact us on +44 (0)20 8996 6325 or complete our Enquiry form.