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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

Workspaces

Hospital
Medical Device Manufacturing Facility
Healthcare Clinic

Occupations

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

Medical Device Risk Evaluation Assessment

(0 / 4)

1
How effective are the implemented risk controls?

Select the effectiveness rating.

To evaluate the effectiveness of risk control measures in reducing risks.
2
Describe the risk management process used for the device.

Provide a detailed description of the risk management process.

To document the specific processes and methodologies applied in risk management.
3
What is the assessed risk level of the medical device?

Rate the risk level from 1 (Very Low) to 5 (Very High).

Understanding the risk level helps in prioritizing risk management activities.
Min: 1
Target: 3
Max: 5
4
Is the risk assessment process compliant with ISO 14971?

Select compliance status.

To ensure adherence to industry standards for medical device risk management.
5
What is the status of the control measures for identified hazards?

Select the current status of control measures.

To assess whether measures are in place to mitigate identified hazards.
6
How many hazards have been identified?

Enter the total number of hazards identified.

To quantify the hazards associated with the medical device for risk evaluation purposes.
Min: 0
Target: 5
Max: 100
7
How is the severity of identified hazards classified?

Select the severity classification for identified hazards.

To ensure that hazards are appropriately categorized based on their potential impact.
8
What method was used for hazard identification?

Describe the method used for hazard identification.

To determine the systematic approach used in identifying potential hazards associated with the medical device.
9
When was the last communication regarding device risks made?

Enter the date of the last communication.

To monitor the frequency of risk communications to stakeholders.
10
Has training been provided to users on risk management?

Indicate whether training has been provided.

To confirm that users are adequately trained to understand and manage risks associated with the device.
11
What is the current awareness level of stakeholders regarding the device's risks?

Select the current awareness level.

To evaluate how well stakeholders understand the risks associated with the medical device.
12
What is the outline of the risk communication plan for the medical device?

Provide a detailed outline of the risk communication plan.

To ensure that there is a clear plan for communicating risks to stakeholders and users.
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13
When was the risk evaluation documentation last updated?

Enter the date of the last update.

To ensure that the documentation is current and reflects the latest risk assessments.
14
How many review cycles has the risk evaluation documentation undergone?

Enter the number of review cycles completed.

To track the thoroughness of the review process for the documentation.
Min: 0
Target: 3
Max: 10
15
How complete is the risk evaluation documentation?

Select the completeness status of the documentation.

To assess whether all necessary components of the documentation are present for compliance.
16
Where is the risk evaluation documentation stored?

Specify the location of the documentation.

To ensure easy access to risk evaluation documentation for review and compliance checks.
17
Provide a description of the key risk mitigation strategies in place.

Describe the key risk mitigation strategies.

To document the specific strategies used for risk mitigation for future reference and audits.
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18
How many risk mitigation strategies have been implemented?

Enter the total number of implemented strategies.

To quantify the efforts made in mitigating identified risks associated with the medical device.
Min: 0
Target: 4
Max: 20
19
Is there a process in place for monitoring the effectiveness of mitigation strategies?

Indicate if effectiveness monitoring is in place.

To ensure that there is a mechanism for assessing the performance of implemented strategies.
20
What is the current implementation status of risk mitigation strategies?

Select the implementation status of mitigation strategies.

To evaluate whether risk mitigation strategies are being executed as planned.

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

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.