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lianhuajin replied to the topic The change from ALARP to AFAP in the forum Risk Analysis for Medical Devices 7 years, 4 months ago
I found that the ALARP concept contains legal interpretation of the regulatory process that promotes financial consideration in higher regard than of the requirements of safety and performance of medical devices. Contradicting this approach, AFAP requires that all ventures of safety must be addressed in the intent of the consumer and effectiveness of the product rather than capital gain of the corporation. Under AFAP standards there are two defined justifications for the lack of implementation of risk-preventative measures. The first indicates that the additional risk control will not provide additional support for the system, such as an additional alarm when a previous alarm is functioning. The second states that a risk control system does not have to be implemented if there is a more effective risk control that can not be simultaneously executed due to various scenarios such as spatial boundaries. By implementing this new standard of risk mitigation, companies must demonstrate that they have considered and implemented all necessary means of addressing risk of a product or developed system.