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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 - Medical Device Risk Management

Workspaces

Clinics
Hospitals
Medical Device Manufacturing Facilities

Occupations

Medical Device Engineer
Quality Assurance Specialist
Risk Manager
Compliance Officer
Healthcare Safety Officer
1
Is the medical device compliant with ISO 14971?
2
What is the risk level score of the device?
Min: 1
Target: 3
Max: 5
3
Describe any identified risks associated with the device.
4
When was the last risk assessment performed?
5
Is ongoing monitoring of the medical device being conducted?
6
What actions have been taken to improve safety related to the device?
7
How many incidents related to the medical device have been reported?
Min: 0
Target: 0
Max: 100
8
When is the next scheduled review of the device's safety compliance?
9
How effective are the current risk mitigation strategies?
10
Is there documentation supporting compliance with ISO 14971?
11
Are emergency protocols established for device-related incidents?
12
When was the last training session conducted on device safety?
13
Is user feedback being regularly collected for the medical device?
14
How many training sessions on device safety have been conducted in the past year?
Min: 0
Target: 4
Max: 20
15
Provide a summary of any incidents reported related to the device.
16
When was the last comprehensive review of the device conducted?
17
Are quality control procedures established for the medical device?
18
What is the quality assessment of the device supplier?
19
What is the defect rate percentage for the medical device?
Min: 0
Target: 2
Max: 100
20
When is the next scheduled quality audit for the medical device?

FAQs

The main focus is to guide the assessment and management of risks associated with medical devices.

Healthcare professionals involved in device safety and risk management should utilize this checklist.

It ensures that risk management practices align with ISO 14971 standards, supporting regulatory compliance.

Key benefits include enhanced device safety, regulatory compliance, and systematic risk management.

This checklist can be applied in hospitals, medical device manufacturing facilities, and healthcare clinics.

Benefits of Medical Device Risk Assessment Checklist

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.