Establish systematic risk management framework defining acceptance criteria responsibilities and lifecycle processes.
Probability | S1 | S2 | S3 | S4 | S5 |
---|---|---|---|---|---|
P1 | Acceptable | Acceptable | Acceptable | Reduce AFAP | Unacceptable |
P2 | Acceptable | Acceptable | Reduce AFAP | Reduce AFAP | Unacceptable |
P3 | Acceptable | Reduce AFAP | Reduce AFAP | Unacceptable | Unacceptable |
P4 | Reduce AFAP | Reduce AFAP | Unacceptable | Unacceptable | Unacceptable |
P5 | Reduce AFAP | Unacceptable | Unacceptable | Unacceptable | Unacceptable |
Role | Responsibilities |
---|---|
Quality Manager | Risk management plan approval, process oversight, regulatory compliance |
Product Manager | Risk assessment participation, user needs input, clinical context |
Software Lead | Software risk analysis, IEC 62304 compliance, cybersecurity risks |
Hardware Lead | Hardware risk analysis, component failure modes, environmental risks |
Clinical Advisor | Clinical risk evaluation, benefit-risk analysis, use-related risks |
How do I determine appropriate risk acceptance criteria for my device?
What level of detail should I include in risk management responsibilities?
How do I integrate risk management with agile development processes?
When should I update my risk management plan during development?
How do I handle risks that cannot be quantified with probability estimates?
What's the relationship between risk management and clinical evaluation?