Publisher's Synopsis
Case histories show that the effects of releasing a device that is unfit for purpose to market can be catastrophic - for those who use the device and the manufacturer. Medical devices must be proven to be fit for purpose before they are marketed. Part of this proof is given by documenting evidence of design verification activities, which show that device design requirements have been met. This workbook - the third in the series - presents an approach for identifying and selecting verification methods, determining when verification should occur in the design process and ensuring that it is carried out within a commercially viable framework.;The workbook is intended to be used by medical device designers, test engineers and project managers in the healthcare manufacturing industry. Readers will benefit from having had some previous experience of medical device design.
