Medical Devices Regulation Booklet

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An increasing number of RQA members have in recent years worked with, or been asked to assist in medical device related projects. The medical device arena is complex; medical devices range from basic tongue depressors to brain stents and pacemakers, with drug/device combination products also included in the family. Information relating to the quality and regulatory aspects of medical devices is not easily accessible, especially if you don't know where to look. RQA identified a need to provide members with a consolidated summary of information on medical devices in one easy booklet.

Contents

1. The Directives
2. Classification
3. Pathways To The CE Marking Conformity Assessment Routes
4. The Role of the Notified Body
5. Essential Requirements
6. Quality Risk Management
7. Clinical Evaluation
8. Technical Documentation
9. Quality Management Systems
10. Post-market surveillance
11. Combination Products
12. Other Regulatory Requirements

Authors

Zelda Carr, Neil Buckley, David Franks, Louise Olliver, Carolyn Mann, Belinda Pierce, Andrew Tipping, Fraser Smith, Merel de Jonge, Alan Dench, Yvanne Enever, Henny Koch, Kevin Butcher, Hannah Jenkins & Julian Reeves.

ISBN

978-1-904610-13-7

Published

First published October 2009, republished July 2013

Discount Information

Discounts are available for bulk orders. Please enter one of the following discount codes:

• BOOK10 for orders of 10 - 19 copies - 25% discount
• BOOK20 for orders of 20 - 49 copies - 33% discount
• BOOK50 for orders over 50 copies - 50% discount

This discount is available for both a block of one title or a combination of titles in hardback.

If ordering 50 or more books for delivery to outside the UK, please contact the RQA office as we will need to calculate the delivery cost for you.

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