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When performed appropriately, summative usability testing, which FDA considers as a form of design validation, quickly reveals whether a manufacturer has effectively addressed users' needs through the application of established human factors processes and principles.
Typically, such testing calls for representative users (e.g., physicians, nurses, therapists, or technicians) to perform frequent, urgent, and critical tasks with the given device, without assistance and possibly without prior training.
Such control entries are discussed in Section 3 of these guidelines.
In more complicated modes of data entry, a user may have to control the format of data inputs as well as their contents.We have implemented the approach in Web DSL, a domain-specific language for the definition of web applications.The term summative usability testing recently entered the lexicon of medical device manufacturers as they faced the new requirement to validate their product's suitability for its intended use.Users might designate position or direction by pointing at a display.Users might enter numbers, letters, or more extended textual material by keyed inputs, or in some applications by spoken inputs.
The member ‘rc’ (or return code) is used to communicate back if the validation was successful or not.