Good design practice for medical devices and equipment - a framework

The research benefited from a very close working relationship with Cambridge Consultants Ltd (CCL). In particular, Duncan Bishop and Stewart Fox contributed a significant amount of their time and gave much valuable advice as work progressed. CCL now make active use of the methodology developed. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means without the prior permission in writing of the publishers, nor be otherwise circulated in any form of binding or cover other than that in which it is published and without a similar condition including this condition being imposed on the subsequent publisher. *The Institute for Manufacturing is also based within the Department of Engineering and includes experts in technology management, international manufacturing, strategy, economic and business performance. It publishes a range of workbooks (see back cover). iv v FORWARD Validation is important in the design, development and production of medical devices, since effective and appropriate validation plays a vital role in defining the success of a product in both technical and economic terms. Regulations and quality standards lay out the requirements for product validation, but it is left to each individual manufacturer to establish and maintain its own validation procedures. More recently, there has also been a change of emphasis in the regulations and standards encouraging the integration of validation into the development process. However, this poses particular challenges to the manufacturer since there is a distinct lack of guidance to assist this integration. This workbook provides the first real guidance on good design practices for medical device development. It has been developed through extensive consultation with device manufacturers and analysis of regulatory requirements. The approach is intended to assist manufacturers in meeting the new regulations. The objective of this workbook is to help people design medical devices and equipment that are easier and more economic to validate. The workbook has been developed to satisfy an industry need for guidance to support concurrent design, development and validation. Regulation in the European Union (EU) and the United States (US) has developed significantly during the last 20 years, moving from a manufacturing process focus to a device design and manufacturing process focus. This is driving the medical device industry to take a more concurrent and integrated approach to design, development and validation. In particular , elements such as design control, which is referred to globally …