Medical Device Risk Management: Design and Process Risks
Device risk management links hazards, controls and evidence across the product lifecycle. Design and production analyses contribute different perspectives. Keeping their relationship clear helps the team recognize when a manufacturing change affects a device risk or when post-market information calls an earlier assumption into question.
Describe the sequence, not just the score
Identify the hazard, the circumstances leading to exposure and the possible harm. Document the rationale for estimates and the evidence behind assumptions. Numerical rankings can help prioritize work, but a score alone does not explain the scenario or establish that a control is effective.
Connect controls with verification and feedback
Choose controls appropriate to the problem and identify how their implementation and effectiveness will be checked. Assess risks after controls and evaluate any new risks they introduce. Feed production and post-market findings back into the analysis. Process failure analysis should address how production can create or fail to detect problems that matter to the finished device.
Practical checklist
Define the product and process boundaries.
Describe hazards and failure sequences.
Record assumptions and supporting evidence.
Assign controls and verification activities.
Review new production and post-market information.
Example
A molding defect may be caught during inspection in one product configuration but remain difficult to detect in another. The process analysis and device risk file should reflect that difference, including the effectiveness of the proposed detection and prevention controls.
Common mistakes
Avoid declaring every risk acceptable because a spreadsheet cell turned green. Keep acceptance criteria, rationale, control evidence and review decisions understandable to someone who was not present during the analysis.
Choose the relevant A.P. Lyon documents
Use the lifecycle risk-management procedure for planning, the risk file, evaluation, controls and ongoing review.
Use design risk management to examine device hazards and the effects of design controls.
Use process risk management to analyze production flow, process failures and associated controls.
Compare the risk-management bundle for coordinated lifecycle, design, process and design-analysis documentation.
Review the product page, document previews and any content list before choosing. Adapt the selected documents to your device, processes and applicable requirements; the organization must generate and review its own implementation evidence.
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