This paper provides a strategy for assessing systems through pulling on some of the techniques introduced in the ISO 26262: 2018 automotive functional safety standard. This will help improve and simplify the risk assessment and development activities of safety relevant medical devices. The approach is systems focussed and relates to medical devices that would come under the remit of IEC 60601-1, hence are defined as ME EQUIPMENT or ME SYSTEMS (medical electrical equipment that transfers energy to or measuring energy from the patient). The approach described demonstrates the great advantage of cross-sectoral learning and the efficiencies that can be created from doing so.
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