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  • I agree with @gaberuiz13 that the tests have to make sense. Specifically, some products already have a set of “gold-standard” validation protocols to follow, such as blood pressure cuff. There are myriads of different kinds of blood pressure cuffs in the market right now. Internationally, these BP products are validated based on protocols established by the British Hypertension Society (BHS), the Association for the Advancement of Medical Instrumentation (AAMI) and, the Working Group on Blood Pressure Monitoring of the European Society of Hypertension (ESH)… and the BHS protocol has been established as early as 1993. So one of these protocols should be a minimum process for a validation protocol if your product has other new features to test (in terms of BP cuffs).

    BHS protocol: http://www.eoinobrien.org/wp-content/uploads/2008/08/x.BHS-Protocol.Revision.J-Hypertens-1993.df_.pdf