Reducing Risks and Recalls: Safety Assurance Cases For Medical Devices

Tool support for assurance case development

“…The TurboAC assurance case tool 42 implements a subset of the core GSN-i.e., goals, strategies, and solutions-and also provides a tabular representation of the created arguments. Additionally, it provides an interface to create fault trees, risktraceability matrices, and to document FMEAs, with primary application to medical device safety assurance [32]. The tool also provides an internal linking mechanism so as to reference the resulting analysis in the arguments created.…”

Cybersecurity for Medical Device Manufacturers: Ensuring Safety and Functionality

“…The typical methods to identify these causes, controls, and interrelationships (i.e., causal chains) include top-down analysis (e.g., fault tree analysis) and bottom-up analysis (e.g., failure mode effects analysis [FMEA]). 7 A risk control eliminates the causes, prevents the causes from becoming hazardous situations or harms, or reduces the severity of potential harms. It is possible to apply multiple risk controls at multiple stages of risk propagation throughout a causal chain leading to harm (Figure 2).…”

Full Issue

“…Lacking a quantitative assessment, the associated logic, qualitative criteria, and rationales should be documented. As discussed previously, 7 assurance cases provide a method for addressing these questions and presenting the information in a format that can facilitate the review process. Table 1 shows the structure of a cybersecurity assurance case and Figures 12 and 13 provide examples with detailed content for the wireless communication asset assurance case.…”