To ensure the safety of the device, the MiDoc vest will mitigate and control the harms and hazards that are foreseeable and/or often occur in predicate devices. We conducted a MAUDE search to look for reports of any adverse events associated with similar medical devices.
that have electrocardiograph function. The reports are grouped and listed according to device
problems.
We then predicted the risks associated with our device. Combining with the results from the MAUDE search, risk analysis was conducted. According to the analysis result, the device poses several risks at different levels. We designed risk controls to mitigate any medium-to-high-risk events.
