Good Design Practice for Medical Devices and Equipment - A Framework
This workbook is aimed at designing medical devices to make them easier and more economic to validate. Recent changes in medical device regulations have forced the industry to focus attention on design and validation in order to ensure that a device and its associated manufacturing, assembly and test equipment are reliable and fit for purpose. In order for this to happen, design must affect validation and validation must affect design. An approach is presented which focuses on the design process to improve the quality of the device and to streamline the validation process. It considers validation, design requirements and risk management of both the device and the related process equipment to be important factors in achieving the improvements.
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