Wi4 Corporation recommends the following risk management basic principles for medical device software design:

  1. Establish a clear and concise goal for the software. The goal should be specific, measurable, achievable, relevant, and time-bound.
  2. Define the system requirements for the software. The requirements should be based on the goal of the software and include specifications for features, functions, performance, and interfaces.
  3. Identify and assess risks associated with the development of the software. Risks should be assessed at all stages of development, from requirements gathering through system testing.
  4. Develop a risk management plan to address identified risks. The plan should include specific actions to mitigate each risk and assigned responsibility for implementing those actions

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