Wi4 Corporation recommends the following risk management basic principles for medical device software design:
- Establish a clear and concise goal for the software. The goal should be specific, measurable, achievable, relevant, and time-bound.
- 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.
- 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.
- 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