ISO 14971 Risk Analysis
Identifying safety risks in medical devices is a challenging and laborious process. The process standard, ISO 14971, is a systematic, total product risk management lifecycle process to identify, control, and evaluate risk, where risk is defined as the combination of severity of the harm (to people, property, or environment) and probability of occurrence of the harm. 14971 defines a general philosophy and process framework but the manufacturer must define and implement a specific policy and procedure for the actual methods they will use to identify, control, and evaluate risks. Different organizations and companies use different methods . . .
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