This checklist is designed to assist in the risk assessment of medical devices, ensuring compliance with ISO 14971 standards and enhancing device safety.
Medical Device Risk Assessment Checklist
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About This Checklist
The Medical Device Risk Assessment Checklist is a crucial tool for healthcare organizations aiming to comply with ISO 14971 standards. This checklist guides professionals through the process of identifying, evaluating, and controlling risks associated with medical devices. By systematically addressing potential hazards, healthcare providers can enhance device safety, ensure regulatory compliance, and protect patient well-being. Keywords: medical device risk assessment, ISO 14971 compliance, healthcare safety, risk evaluation.
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Facilitates comprehensive risk assessment for medical devices.
Ensures compliance with ISO 14971 standards.
Enhances device safety and patient protection.
Supports regulatory compliance and reduces risk-related liabilities.
Promotes a systematic approach to risk management.
