Medical Device Risk Acceptance Checklist

This checklist is designed to assist in the evaluation and acceptance of residual risks for medical devices, ensuring compliance with ISO 14971 standards and enhancing device safety.

Medical Device Risk Acceptance Checklist
by: audit-now
4.4

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About This Checklist

The Medical Device Risk Acceptance Checklist is an essential tool for healthcare organizations aiming to comply with ISO 14971 standards. This checklist aids in the evaluation and acceptance of residual risks associated with medical devices, ensuring that all risks are within acceptable levels before product release. By using this checklist, healthcare providers can enhance device safety, ensure regulatory compliance, and make informed decisions regarding risk acceptance. Keywords: risk acceptance, ISO 14971 compliance, medical device safety, healthcare risk management.

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Industry

Healthcare

Standard

ISO 14971

Workspaces

Hospital
Medical Device Manufacturing Facility
Healthcare Clinic

Occupations

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

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