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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

Workspaces

Hospital
Medical Device Manufacturing Facility
Healthcare Clinic

Occupations

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

Medical Device Risk Assessment Checklist

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1
When was the last risk assessment performed?

Select the date of the last risk assessment.

To track the frequency of risk assessments for compliance and safety.
2
Describe any identified risks associated with the device.

Provide a detailed risk description.

To document specific risks that may impact patient safety.
3
What is the risk level score of the device?

Enter the risk level score (1-5).

To quantify the risk associated with the medical device based on its assessment.
Min: 1
Target: 3
Max: 5
4
Is the medical device compliant with ISO 14971?

Select the compliance status of the device.

To ensure that the medical device meets regulatory standards for risk management.
5
When is the next scheduled review of the device's safety compliance?

Select the date for the next review.

To ensure timely reviews of device compliance and safety.
6
How many incidents related to the medical device have been reported?
To track the number of incidents for evaluating device safety.
Min: 0
Target: 0
Max: 100
7
What actions have been taken to improve safety related to the device?

Provide details of safety improvement actions.

To document specific actions taken to enhance the safety of the medical device.
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8
Is ongoing monitoring of the medical device being conducted?

Select the current monitoring status.

To ensure that the device is continuously assessed for safety and performance.
9
When was the last training session conducted on device safety?

Select the date and time of the last training.

To ensure that staff is regularly trained on safety protocols regarding the device.
10
Are emergency protocols established for device-related incidents?

Indicate whether emergency protocols are established.

To ensure that protocols are in place for responding to emergencies involving the device.
11
Is there documentation supporting compliance with ISO 14971?

Provide a summary of compliance documentation.

To verify that adequate documentation exists to demonstrate compliance.
12
How effective are the current risk mitigation strategies?

Select the effectiveness level of risk mitigation strategies.

To evaluate the success of strategies implemented to reduce risks associated with the device.
13
When was the last comprehensive review of the device conducted?

Select the date of the last comprehensive review.

To ensure regular evaluations of the device's safety and effectiveness.
14
Provide a summary of any incidents reported related to the device.

Detail any incidents and their analysis.

To document and analyze incidents for ongoing risk management.
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15
How many training sessions on device safety have been conducted in the past year?
To evaluate the effectiveness of training programs for safe device usage.
Min: 0
Target: 4
Max: 20
16
Is user feedback being regularly collected for the medical device?

Select the frequency of user feedback collection.

To ensure that user experiences and concerns are monitored for safety and efficacy.
17
When is the next scheduled quality audit for the medical device?

Select the date for the next quality audit.

To ensure that regular audits are conducted to maintain quality assurance.
18
What is the defect rate percentage for the medical device?
To monitor the rate of defects to ensure product reliability and safety.
Min: 0
Target: 2
Max: 100
19
What is the quality assessment of the device supplier?

Provide details of the supplier quality assessment.

To evaluate the supplier's capability to provide high-quality components for the device.
20
Are quality control procedures established for the medical device?

Select the status of quality control procedures.

To ensure that appropriate quality control measures are in place to maintain device standards.

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

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.