A comprehensive checklist designed to guide medical device manufacturers in systematically reviewing and analyzing production and post-production information to maintain effective risk management throughout the product lifecycle, in compliance with ISO 14971 standards.
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About This Checklist
The ISO 14971 Production and Post-Production Information Review Checklist is a crucial tool for medical device manufacturers to ensure ongoing risk management throughout the product lifecycle. This checklist guides organizations in systematically collecting, analyzing, and acting upon information gathered during production and post-production phases. By implementing this checklist, companies can effectively identify new or changed risks, evaluate the impact on existing risk assessments, and initiate appropriate actions to maintain product safety and performance. This proactive approach aligns with ISO 14971 requirements for continuous risk management and supports regulatory compliance while enhancing patient safety.
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The primary focus is on systematically reviewing and analyzing information gathered during production and post-production phases to identify new risks, evaluate existing risk assessments, and initiate necessary actions to maintain product safety and effectiveness.
The checklist covers sources such as production data, customer feedback, complaint records, adverse event reports, post-market surveillance data, scientific literature, and regulatory updates.
Reviews should be conducted on an ongoing basis, with formal assessments typically performed quarterly or semi-annually, and immediate reviews triggered by significant events or new information.
By ensuring regular review of real-world data, the checklist helps validate initial risk assessments, identify new hazards, and drive continuous improvement in risk control measures throughout the product lifecycle.
The process should involve a cross-functional team including quality assurance, regulatory affairs, product management, engineering, and clinical affairs representatives to ensure comprehensive analysis and appropriate action.
Benefits of ISO 14971 Production and Post-Production Information Review Checklist
Ensures continuous risk management beyond the design phase
Facilitates early detection of emerging risks or safety issues
Supports compliance with ISO 14971 and regulatory requirements
Improves product quality and safety through data-driven insights
Enhances manufacturer responsiveness to real-world product performance