ISO 14971 Medical Device Risk Management Audit Checklist

A comprehensive audit checklist designed to assess compliance with ISO 14971 standards for risk management in medical devices, covering all aspects of the risk management process from initial analysis to post-production monitoring.

ISO 14971 Medical Device Risk Management Audit Checklist
by: audit-now
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About This Checklist

The ISO 14971 Medical Device Risk Management Audit Checklist is an essential tool for healthcare professionals and medical device manufacturers to ensure compliance with international standards for risk management in medical devices. This comprehensive checklist addresses the critical aspects of risk assessment, control, and monitoring throughout the product lifecycle. By implementing this checklist, organizations can effectively identify potential hazards, mitigate risks, and enhance patient safety. The systematic approach provided by this checklist helps streamline the audit process, ensuring thorough coverage of all relevant ISO 14971 requirements.

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Industry

Healthcare

Standard

ISO 14971

Workspaces

Medical Device Manufacturing Facility

Occupations

Quality Assurance Manager
Regulatory Affairs Specialist
Medical Device Engineer
Risk Management Specialist
Healthcare Auditor

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