SOP Risk Management

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Summary

Your Risk Management SOP establishes a systematic process for identifying, analyzing, evaluating, and controlling risks throughout the medical device lifecycle, ensuring patient and user safety while maintaining device functionality and compliance with ISO 14971:2019 requirements.

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Why is SOP Risk Management important?

Risk management exists because medical devices can potentially harm patients or users if risks are not properly identified and controlled. Regulators require systematic risk management to demonstrate that manufacturers have proactively considered potential hazards and implemented appropriate controls before devices reach the market.

The SOP ensures consistent risk assessment across all development phases and provides a framework for making risk-based decisions about design, testing, and post-market activities. It transforms risk management from reactive problem-solving into proactive safety engineering that builds confidence with regulators, customers, and internal stakeholders.

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Regulatory Context

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Guide

Your Risk Management SOP provides the foundation for systematic safety assessment throughout the device lifecycle. Structure the process to be comprehensive yet practical for your organization size and device complexity.

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Risk Management Planning

Establish a comprehensive risk management plan that defines scope, responsibilities, risk acceptance criteria, and review requirements. The plan should align with your development timeline and integrate with design controls, validation activities, and post-market surveillance.

Create risk acceptance criteria that reflect your device’s intended use, patient population, and clinical environment. Use a risk matrix approach that considers both probability and severity, with clear definitions for acceptable, tolerable, and unacceptable risk levels.

Define responsibilities and authorities for risk management activities, including who can approve risk assessments, accept residual risks, and authorize risk control measures. Ensure appropriate expertise is assigned to risk management activities.

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Hazard Identification and Risk Analysis

Conduct systematic hazard identification that considers all foreseeable hazards including hardware failures, software malfunctions, user errors, environmental factors, and cybersecurity threats. Use structured approaches like fault tree analysis, failure mode analysis, or hazard analysis techniques.

Perform risk estimation by evaluating the probability of hazardous situations occurring and the severity of potential harm. Consider factors like device complexity, use environment, user training, and patient vulnerability when estimating risks.

Document traceability from hazards through hazardous situations to potential harms, ensuring that risk controls address the complete causal chain. This traceability is critical for regulatory submissions and audit evidence.

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Risk Control Implementation

Implement risk controls following the hierarchy of controls: inherently safe design, protective measures, and information for safety. Prioritize design-based controls over user training or warnings whenever possible.

Verify risk control effectiveness through testing, analysis, or other objective methods. Ensure that risk controls actually reduce risks to acceptable levels and don’t introduce new unacceptable risks.

Conduct residual risk evaluation after implementing controls to confirm that remaining risks are acceptable and that the overall benefit-risk balance is positive.

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Risk Management Integration

Connect risk management with design controls by using risk assessment outputs to inform design inputs, verification activities, and validation requirements. Risk management should guide development decisions throughout the design process.

Integrate with post-market activities by establishing mechanisms to collect and evaluate risk-related information from complaints, adverse events, and performance monitoring. Use this information to reassess risks and implement additional controls if needed.

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Risk Management File Documentation

Maintain a comprehensive risk management file that provides traceability from hazard identification through risk control implementation and verification. Include risk management plan, risk assessments, risk control measures, verification evidence, and post-market risk information.

Ensure the risk management file supports regulatory submissions with clear documentation of risk management process compliance and evidence of systematic risk assessment and control.

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Example

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Scenario

BioTech Diagnostics develops a portable blood glucose meter for home use by diabetic patients. They implement comprehensive risk management to identify potential hazards, assess risks, and implement controls to ensure patient safety while maintaining device functionality.

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Example Risk Management Implementation

Risk Management Plan:

• Scope: Complete device lifecycle from design through post-market surveillance
• Risk Acceptance Criteria: 5x5 matrix with probability vs. severity levels
• Responsibilities: Product team identifies hazards, quality team reviews assessments
• Review Schedule: Risk assessment updates at each design phase gate

Hazard Identification:

• Device Component Analysis: Battery failure, display malfunction, test strip compatibility
• User Interface Hazards: Confusing readings, difficult button operation
• Environmental Factors: Temperature effects, moisture damage, electromagnetic interference
• User Error Scenarios: Wrong test strip insertion, contaminated samples, missed calibration

Risk Assessment Example:

• Hazard: Incorrect glucose reading due to test strip contamination
• Hazardous Situation: Patient receives false low glucose reading
• Potential Harm: Patient doesn’t treat actual high glucose, leading to diabetic complications
• Probability: Occasional (test strips exposed to moisture)
• Severity: Serious (delayed treatment of hyperglycemia)
• Risk Level: Unacceptable - requires risk control measures

Risk Controls Implemented:

1. Inherent Safety: Individual foil-sealed test strip packaging
2. Protective Measures: Error codes for invalid readings, automatic calibration verification
3. Information for Safety: Clear instructions for proper test strip storage and handling

Verification Activities:

• Environmental testing confirms moisture protection effectiveness
• User testing validates error message clarity and user response
• Clinical accuracy testing verifies reading reliability under normal and edge conditions

Residual Risk Evaluation:

• After controls: Probability reduced to “Remote,” Risk level now “Acceptable”
• Benefit-risk analysis confirms positive benefit-risk balance
• Overall residual risk acceptable for intended patient population

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Q&A