ISO 14971 Post-Production Risk Monitoring Checklist

A specialized checklist designed to guide the post-production risk monitoring process for medical devices, ensuring ongoing compliance with ISO 14971 standards and facilitating continuous improvement in product safety and performance.

ISO 14971 Post-Production Risk Monitoring Checklist
by: audit-now
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About This Checklist

The ISO 14971 Post-Production Risk Monitoring Checklist is a crucial tool for healthcare organizations and medical device manufacturers to ensure ongoing compliance with risk management standards after product release. This checklist focuses on the critical phase of post-market surveillance, helping to identify and address emerging risks, adverse events, and opportunities for product improvement. By implementing this checklist, companies can maintain vigilance over their products' safety and performance, respond promptly to new information, and continuously enhance patient safety. The structured approach provided by this checklist aids in meeting regulatory requirements and maintaining the integrity of risk management systems throughout the product lifecycle.

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Industry

Healthcare

Standard

ISO 14971

Workspaces

Medical Device Company Offices

Occupations

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

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