ISO 14971 Production and Post-Production Information Review Checklist

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.

ISO 14971 Production and Post-Production Information Review Checklist
by: audit-now
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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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Industry

Healthcare

Standard

ISO 14971

Workspaces

Medical Device Manufacturing and Corporate Offices

Occupations

Quality Assurance Specialist
Post-Market Surveillance Manager
Regulatory Affairs Coordinator
Product Safety Engineer
Clinical Data Analyst

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