How should medical device risk control measures be validated?
Verification includes the verification of risk control measures and the verification of the effectiveness of risk control measures. One is to verify whether the required control measures; one is to verify that the measures implemented really reduce the risk. The former is easy to understand and implement, the latter usually refers to the implementation of design measures, protective measures and safety information, whether to reduce the severity of potential damage, reduce the probability of damage or both; and re-estimate the probability and/or severity of damage, the combined estimated level of residual risk compared with the level of risk before taking measures, to verify whether it is indeed a reduction in risk.