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djr32 replied to the topic Risk Management in the forum Project Management Process and Medical Device Development 8 years, 7 months ago
A medical device is my capstone project, AudIQ, which is a mobile application that trains people with hearing aid’s auditory cues. One possibility of risk of the product is the application does not control the level of sound it outputs when training. This risk can be detrimental to the user because an app that is meant to help someone’s hearing can potentially damage one’s hearing. This can even cause customers to avoid purchasing the app. My team and I managed this risk by building an algorithm that decreased the volume level to a safe setting whenever the app was opened. Moreover, we did not want to lower the voice too low that the sound was not even audible. So thus, an algorithm in the app lowered the volume to a default safe volume. This is using the avoidance technique to handle the risk. Some ways to measure the risk is to conduct a literature search on what volume is safe for hearing. Then, apply this finding in the algorithm. After the algorithm is implemented in the app, we can run the application and observe if the algorithm set the volume to a safe level when the application starts up.