Given the critical role that software plays in modern healthcare, it’s no surprise that medical device software risk management is a major focus for the industry. Risk management is the process of identifying, assessing, and controlling risks to ensure that exposure to hazards is minimized. In the context of medical device software, risk management includes activities like identifying potential hazards associated with the use of a particular software application, assessing the risks posed by those hazards, and implementing controls to mitigate or eliminate those risks.

There are a variety of factors that need to be considered when conducting a medical device software risk assessment.

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