Analyzing Risk in Medical Devices is that required

Why should we perform risk analysis?

1. Risk analysis is now required by law (Revised GMP, see below)
2. Identification of device design problems prior to distribution eliminates costs associated with recalls.
3. It offers a measure of protection from product liability damage awards.
4. Regulatory submissions checklists (PMA and 510k) used by the FDA now call for inclusion of risk analysis.
5. It is the right thing to do.


“Pre-production Quality Assurance Planning Recommendations For Medical Device Manufacturers” identifies three tools for risk analysis: 1. Failure mode effects analysis (FMEA),
2. Fault tree analysis (FTA), and Failure mode effects criticality analysis (FMECA)
3. Failure Mode Effects Analysis (FMEA) and Failure Mode Effects Criticality Analysis (FMECA)

Failure mode effects analysis (FMEA) is a “bottom up” approach which assumes a basic defect at the component level, assesses the effect, and identifies potential solutions. It should be conducted at the beginning of the design effort and as part of each design review to identify potential design weaknesses. Failure mode effects criticality analysis (FMECA) adds probability of occurrence and severity of failure to the FMEA process.

The steps of the FMEA process:

• Define the function of the unit being analyzed.
• Identify all potential failures.
• Determine the causes of each failure types.
• Determine the effects of potential failures.
• Assign a risk index to each of the failure types.
• Determine the most appropriate corrective/preventive actions.
• Monitor the implementation of the corrective/preventive to ensure that it is having the desired effect.

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