Module 16 2022

Recap: 1) Identifying hazards and hazardous conditions associated with a medical device that could place patients or healthcare workers at risk. 2) Estimating the potential occurrence of such risks, and evaluating the extent of the consequences. 3) Developing and implementing active safeguards within the device or the production process to control risks. 4) Regularly reviewing and monitoring the process to assess the effectiveness of risk management

Risk = Severity of Harm (S) x Probability of Occurrence of Harm (POH).

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