What should be included in the risk management review of devices?

Date:2023-01-09
1. Identification of risks associated with the device, such as cybersecurity vulnerabilities, safety risks and environmental impacts. 2. Creation of a risk register, including the likelihood and consequences of the identified risks. 3. Identification of the attention and resources required to reduce the identified risks. 4. Creation of procedures for performing a risk assessment and related testing. 5. Identification of available strategies for managing the identified risks. 6. Documentation of the risk management process and any resulting decisions or changes. 7. Development of contingency plans for addressing the identified risks. 8. Monitoring and evaluation to ensure risks are managed consistently. 9. A communication plan to ensure that stakeholders are informed regarding risks and actions taken to manage them.
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