Medical product design documentation

The extent to which usability can impact safety has long been established and the design and evaluation techniques involved are well documented in the literature [1, 2]. For medical devices, there is usually an explicit regulatory requirement to execute an evaluation which often translates into complying with Standard ISO 62366 2007 [3] or specific FDA requirements [4]. These approaches may be overkill for HIT which falls short of regulation. Nevertheless a great deal can be learnt from these requirements and their methods be applied to an extent commensurate with the risk to non-medical device HIT products. 

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