Design Risk Management Procedure
Analyze device design risks with this editable ISO 14971:2019 Design Risk Management Procedure and Excel worksheets. It guides hazard identification, risk estimation, control selection and reassessment after controls as part of the overall medical device risk-management process.
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Editable Microsoft Word and Excel files, with related forms, supplied as a digital download.
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.
The included Excel worksheets and related forms guide the following steps:
Preparation Steps
Risk Identification
Risk Estimation
Preliminary Risk Level
Risk Control Measures
Re-Estimation of Risk Post Implementation of Controls
Design risk assessment
The design risk procedure guides the team from preparation and hazard identification through estimation of severity and probability. Its worksheet structure links intended use, part function, failure modes, causes and possible patient or user harm to the proposed controls.
Control and continuing review
Risk estimates and control measures are reviewed as design evidence develops. A design change or post-market signal can trigger reassessment, keeping the risk record connected to the current device design.
Use this focused procedure with the overarching Risk Management Procedure and the Design Analysis Procedure.
Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.
Practical guide
Read Medical Device Risk Management: Design and Process Risks for workflow guidance, a checklist and common mistakes.
Part of a procedure bundle
This document is also included in Risk Management Procedures Bundle. Explore the bundle for the related documents.
