Alexander, KL and Clarkson, PJ and Bishop, D (1999) Designing for validation of medical devices and equipment. Technical Report. Cambridge University Engineering Department, Cambridge, UK.Full text not available from this repository.
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 their own validation procedures. More recently, there has also been a change of emphasis in the regulations and standards that encourage 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.
|Item Type:||Monograph (Technical Report)|
|Additional Information:||CUED/C-EDC/TR.89. ISSN 0963-5432.|
|Uncontrolled Keywords:||theme="Healthcare Design"|
|Divisions:||Div C > Engineering Design|
|Depositing User:||Cron Job|
|Date Deposited:||28 Oct 2011 16:55|
|Last Modified:||10 Dec 2012 01:06|
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