Good Design Practice for Medical Devices and Equipment - Design Verification
Medical devices must be proven to be fit for purpose before they are placed on the market. Part of this proof is given by documenting evidence of design verification activities, which show that device design requirements have been met. This workbook 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, thereby improving the chances of developing a device that is fit for purpose within the bounds of commercial reality. Ideally, it should be used in conjunction with pre-existing working practices and, perhaps even more importantly, in addition to the array of regulations for medical device design.
This workbook is free to download.