Medical Device Risk Assessment Checklist

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
by: audit-now
4.1

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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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Industry

Healthcare

Standard

ISO 14971

Workspaces

Hospital
Medical Device Manufacturing Facility
Healthcare Clinic

Occupations

Medical Device Engineer
Quality Assurance Specialist
Risk Manager
Compliance Officer
Healthcare Safety Officer

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