The Risk-Benefit analysis has to be performed, when the residual risk is not judged as acceptable using the criteria established in the risk management plan, and further risk control is not practicable, then the manufacturer may gather and review data and literature to determine if the medical benefits of the intended use of the medical …
Risk Evaluation Approaches- ALARP Vs AFAP
As-Iow-as-reasonably-practicable approach(ALARP) - is that the residual risk shall be reduced as far as reasonably practicable and this approach can be used as part of risk control options analysis. Risks for which the probability cannot be estimated would normally use the as-low-as-reasonably-practicable approach. the ALARP concept contains legal interpretation of the regulatory process that promotes financial consideration …
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Medical Device CE Marking 