Abstract: A process and system for generating a specification for customized devices, such as rehabilitation or assistive devices, including prostheses and orthoses, or sports padding or equipment. A digital model, which is fully parameterized at least for characterizing clinical shape characteristics and functional characteristics of the device, is populated with a plurality of design parameter values and 3-dimensional coordinates of captured and calculated virtual landmarks to construct a customized model corresponding to the specification. The customized device may be manufactured based upon the specification. A system connected to a computer aided manufacturing system may generate instructions for automatically fabricating the device. In embodiments with standardized design parameter values, the customized model may be constructed without involving a human operator.