SOP Post-Market Surveillance

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Summary

Your Post-Market Surveillance (PMS) SOP establishes systematic processes for actively collecting, analyzing, and acting on real-world data about your device’s safety, performance, and quality throughout its entire lifecycle to support continuous improvement and regulatory compliance.

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Why is SOP Post-Market Surveillance important?

Post-market surveillance exists because regulators recognize that real-world performance may differ from controlled study conditions. It demonstrates your commitment to ongoing safety monitoring rather than treating regulatory approval as the end of your responsibility. The systematic collection of field data helps identify previously unknown risks and validates clinical assumptions.

Your PMS system transforms scattered customer feedback into actionable intelligence that drives product improvements, informs regulatory decisions, and protects patients. It also provides early warning signals for potential issues before they become serious incidents requiring immediate regulatory action, allowing proactive rather than reactive responses.

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Regulatory Context

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Guide

Your PMS SOP establishes proactive monitoring systems that transform real-world data into actionable insights. Focus on creating sustainable processes that provide meaningful intelligence rather than just compliance documentation.

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PMS Plan Development

Create device-specific PMS plans that outline systematic data collection methods, analysis procedures, and decision criteria. Define clear objectives, target populations, data sources, and collection methods appropriate for your device type and risk classification. Include specific indicators and threshold values for triggering actions.

Establish systematic procedures for collecting information from multiple sources including customer complaints, scientific literature, vigilance databases, user feedback, and competitive intelligence. Design collection methods that provide representative and meaningful data rather than overwhelming your team with low-value information.

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Data Collection and Sources

Implement multi-channel data collection systems that capture diverse perspectives on device performance. Include direct customer feedback, distributor reports, scientific literature monitoring, regulatory database searches, and social media monitoring where appropriate. Create standardized forms and procedures to ensure consistent data quality.

Establish partnerships with key stakeholders including distributors, healthcare providers, and patient advocacy groups to enhance data collection capabilities. Include procedures for validating and verifying collected information to ensure reliability and accuracy.

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Analysis and Evaluation Methods

Develop systematic analysis procedures that transform raw data into meaningful insights. Include trend analysis methodologies, statistical significance testing, and benefit-risk assessment procedures. Establish clear criteria for determining when findings require action versus continued monitoring.

Create analysis workflows that involve appropriate subject matter experts including clinical specialists, risk management personnel, and regulatory affairs professionals. Include procedures for documenting analysis methods and results to support regulatory submissions and audits.

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Integration with Quality System

Connect PMS outputs to all relevant quality processes including CAPA, risk management, design controls, and clinical evaluation updates. Establish clear triggers for initiating corrective actions, design changes, or regulatory notifications based on PMS findings.

Include PMS data in management review reporting with trending analysis and performance indicators. Use PMS insights to inform strategic decisions about product improvements, market expansion, and risk management priorities.

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Reporting and Communication

Establish systematic reporting procedures that meet regulatory requirements while providing meaningful information to stakeholders. Create templates and workflows for PSUR development, trend reporting, and regulatory submissions that ensure consistency and completeness.

Develop communication procedures for sharing findings with relevant stakeholders including customers, distributors, regulatory authorities, and notified bodies. Include procedures for coordinating with other manufacturers when systemic issues affect multiple devices.

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Example

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Scenario

MedTech Solutions implements post-market surveillance for their diabetes monitoring app, collecting data from user feedback, app store reviews, customer support interactions, and clinical literature to monitor real-world performance and identify improvement opportunities.

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PMS System Implementation

PMS Plan Development:

• Data Sources: App analytics, customer support tickets, app store reviews, clinical literature, competitive intelligence
• Collection Methods: Automated data extraction, customer surveys, healthcare provider feedback forms
• Analysis Frequency: Monthly trending analysis, quarterly comprehensive review
• Threshold Values: >5% increase in crash reports, >3 complaints about accuracy per month
• Action Criteria: Statistical significance testing for trends, severity-based escalation procedures

Data Collection Implementation:

1. Technical Performance Monitoring: Automated collection of crash reports, performance metrics, usage patterns
2. Customer Feedback Systems: In-app feedback portal, quarterly satisfaction surveys, support ticket analysis
3. Literature Monitoring: Monthly PubMed searches, regulatory database monitoring, competitor analysis
4. Healthcare Provider Input: Semi-annual provider surveys, clinical outcome data collection
5. Social Media Monitoring: Automated scanning of relevant platforms for device mentions and issues

Analysis and Response Example: Finding: 8% increase in glucose reading accuracy complaints over 3-month period Investigation: Root cause analysis reveals algorithmic performance degradation with specific phone models Analysis: Risk assessment indicates potential for delayed insulin administration decisions Actions:

• Immediate: Customer advisory notice with workaround instructions
• Short-term: Software update addressing compatibility issue
• Long-term: Enhanced device compatibility testing procedures Follow-up: Monitor complaint resolution and customer satisfaction improvement

PSUR Development Process:

• Data Compilation: Systematic review of all PMS data collected during reporting period
• Trend Analysis: Statistical analysis of complaint patterns, performance metrics, usage data
• Clinical Review: Assessment of real-world performance versus intended use claims
• Risk Assessment: Updated benefit-risk analysis incorporating new field data
• Action Planning: Identification of improvement opportunities and regulatory update needs

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Q&A