A Risk Driven Approach to testing Medical Device Software
Software for medical devices is strongly driven by regulatory requirements. Among those, safety assurance is critical. To achieve the required high levels of safety, it is essential to reliably reduce safety risks to a residual low level. This requirement is verified and validated mostly with software testing. An approach to software testing driven by safety risks is presented and complemented with comments from a real project where it has been applied. Specific comments to improve test design so as to detect more safety risks and issues are also provided based on experiences from the same project.
KeywordsMedical Device Software Testing Risk Mitigation Residual Risk Risk Item
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