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This template outlines a systematic approach to identify hazards associated with the device, estimate and evaluate these risks, implement controls to mitigate such risks, and monitor the effectiveness of these controls. This plan is developed in accordance with the standard EN ISO 14971:2019/A11:2021 and guideline ISO/TR 24971:2020 to ensure regulatory compliance and adherence to best practices in risk management. Aligned with regulatory requirements, this plan details the process for hazard identification, risk estimation, and evaluation. It outlines the criteria for assessing risk acceptability and determining appropriate risk controls. Furthermore, the plan includes provisions for monitoring the effectiveness of implemented risk controls through periodic evaluations and reviews. By establishing clear procedures and responsibilities, this plan ensures a proactive approach to managing risks associated with the device throughout its lifecycle.
This template is designed by highly experienced professionals for all medical device companies. Click below to get a preview of this template.
