Design Risk Management Procedure

The ISO 14971:2019 Design Risk Management Procedure focuses on design elements of the risk management process. The design risk management procedure is aligned with the requirements of ISO 14971:2019.

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Design Risk Management Procedure

The Design Risk Management Procedure defines the process for conducting design risk analysis for risks associated with medical products. This procedure is made part of the overall risk management process.

Design Risk Management Procedure - Overview

The Design Risk Management Procedure provides detailed instruction on the following steps:The Design Risk Management Procedure includes excel spreadsheets and related forms with instructions for each step of the process.

• Preparation Steps

• Risk Identification

• Risk Estimation

• Preliminary Risk Level

• Risk Control Measures

• Re-Estimation of Risk Post Implementation of Controls