This checklist is designed to assist in the evaluation and control of risks associated with medical devices, ensuring compliance with ISO 14971 standards and enhancing device safety.
Medical Device Risk Evaluation and Control Checklist
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About This Checklist
The Medical Device Risk Evaluation and Control Checklist is a comprehensive tool for healthcare organizations dedicated to ISO 14971 compliance. This checklist guides professionals through the evaluation of identified risks and the implementation of appropriate control measures to mitigate them. By utilizing this checklist, healthcare providers can ensure device safety, maintain regulatory compliance, and enhance patient protection. Keywords: risk evaluation, risk control, ISO 14971 compliance, medical device safety.
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Facilitates thorough evaluation and control of medical device risks.
Ensures compliance with ISO 14971 standards.
Enhances safety and reliability of medical devices.
Supports effective risk mitigation strategies.
Improves patient protection by addressing risks comprehensively.
