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Medical Device Risk Evaluation Checklist

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

Medical Device Risk Evaluation Checklist

by: audit-now
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About This Checklist

The Medical Device Risk Evaluation Checklist is a vital tool for healthcare organizations committed to adhering to ISO 14971 standards. This checklist assists in the systematic evaluation of risks associated with medical devices, ensuring that all potential hazards are thoroughly assessed and prioritized. By employing this checklist, healthcare providers can enhance device safety, ensure regulatory compliance, and improve patient care outcomes. Keywords: risk evaluation, ISO 14971 compliance, medical device assessment, healthcare safety.

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Industry

Healthcare

Standard

ISO 14971 - Medical Device Risk Management

Workspaces

Hospitals
Clinics
Medical Device Manufacturing Facilities

Occupations

Medical Device Engineer
Risk Manager
Quality Assurance Specialist
Compliance Officer
Healthcare Safety Officer
1
Is the risk assessment process compliant with ISO 14971?
2
What is the assessed risk level of the medical device?
Min: 1
Target: 3
Max: 5
3
Describe the risk management process used for the device.
4
How effective are the implemented risk controls?
5
What method was used for hazard identification?
6
How is the severity of identified hazards classified?
7
How many hazards have been identified?
Min: 0
Target: 5
Max: 100
8
What is the status of the control measures for identified hazards?
9
What is the outline of the risk communication plan for the medical device?
10
What is the current awareness level of stakeholders regarding the device's risks?
11
Has training been provided to users on risk management?
12
When was the last communication regarding device risks made?
13
Where is the risk evaluation documentation stored?
14
How complete is the risk evaluation documentation?
15
How many review cycles has the risk evaluation documentation undergone?
Min: 0
Target: 3
Max: 10
16
When was the risk evaluation documentation last updated?
17
What is the current implementation status of risk mitigation strategies?
18
Is there a process in place for monitoring the effectiveness of mitigation strategies?
19
How many risk mitigation strategies have been implemented?
Min: 0
Target: 4
Max: 20
20
Provide a description of the key risk mitigation strategies in place.

FAQs

The main objective is to guide the systematic evaluation of risks associated with medical devices.

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

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

Key benefits include enhanced device safety, regulatory compliance, and improved patient care outcomes.

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

Benefits of Medical Device Risk Evaluation Checklist

Facilitates comprehensive evaluation of medical device risks.

Ensures compliance with ISO 14971 standards.

Enhances safety and reliability of medical devices.

Supports informed decision-making in risk management.

Improves patient care outcomes by mitigating device risks.