The Medical Devices Introductory Course 2020

ISO 14971:2019 Overview of structure and contents

6 Risk evaluation

For each identified hazardous situation, the manufacturer shall evaluate the estimated risks and determine if the risk is acceptable or not, using the criteria for risk acceptability defined in the risk management plan. If the risk is acceptable, it is not required to apply the requirements given in 7.1 to 7.5 to this hazardous situation (i.e., proceed to 7.6) and the estimated risk shall be treated as residual risk. If the risk is not acceptable, then the manufacturer shall perform risk control activities as described in 7.1 to 7.6.

The results of this risk evaluation shall be recorded in the risk management file.

The Organisation for Professionals in Regulatory Affairs

BS EN ISO 14971: Overview of structure and contents

The Organisation for Professionals in Regulatory Affairs