Design verification support for the medical device industry

摘要

Engineering products should be demonstrated to be fit for their intended purpose before they are released onto the market. Design verification is one such evaluative activity, and involves the comparison of 'design outputs' (the products of a design-related task such as drawings, risk analysis results and test results) against 'design inputs' (the requirements for the design). This comparison occurs regularly throughout the device design process as the various requirements are embodied, and involves a range of methods, such as tests, analyses and simulations.