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Medical Device Risk Evaluation and Control Checklist

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

Medical Device Risk Evaluation and Control Checklist

by: audit-now
4.6

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About This Checklist

The Medical Device Risk Evaluation and Control Checklist is a comprehensive tool for healthcare organizations dedicated to ISO 14971 compliance. This checklist guides professionals through the evaluation of identified risks and the implementation of appropriate control measures to mitigate them. By utilizing this checklist, healthcare providers can ensure device safety, maintain regulatory compliance, and enhance patient protection. Keywords: risk evaluation, risk control, ISO 14971 compliance, medical device safety.

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Industry

Healthcare

Standard

ISO 14971 - Medical Device Risk Management

Workspaces

Hospitals
Medical Device Manufacturing Facilities
Clinics

Occupations

Risk Manager
Medical Device Engineer
Quality Assurance Specialist
Compliance Officer
Healthcare Safety Officer
1
Is the risk assessment process compliant with ISO 14971 standards?

Select compliance status.

To ensure that the risk assessment meets required regulations for medical device safety.
2
What is the effectiveness rating of the implemented risk controls (on a scale of 1 to 5)?

Rate the effectiveness of the risk controls.

To evaluate how well the risk controls are functioning in practice.
Min: 1
Target: 5
Max: 5
3
Please provide a summary of the most recent risk evaluation conducted.

Enter a summary of the risk evaluation.

To maintain a record of risk evaluations for future reference and compliance.
4
What is the current status of the risk management plan?

Select current status.

To track the progress of the risk management plan implementation.
5
What is the implementation status of the identified risk controls?

Select the implementation status.

To ensure that all identified risk controls are being implemented as planned.
6
Please upload the documentation related to the risk assessment.

Attach relevant documents or notes.

To have a formal record of the risk assessment process for review and compliance.
7
What is the residual risk level after implementing controls (on a scale of 1 to 10)?

Enter a value for residual risk level.

To evaluate the level of risk that remains after controls have been implemented.
Min: 1
Target: 3
Max: 10
8
When was the last review of the risk management process conducted?

Select the date of the last review.

To ensure that the risk management process is regularly reviewed and updated.
9
How effective is the current risk identification process?

Select the effectiveness level.

To assess the adequacy of the risk identification methods in place.
10
Have all relevant personnel received training on risk management procedures?

Indicate whether training has been completed.

To ensure that all staff are knowledgeable about risk management protocols.
11
How many risks were identified in the last risk assessment?

Enter the total number of identified risks.

To keep track of the risk landscape and ensure thorough assessments.
Min: 0
Target: 10
Max: 100
12
When is the next scheduled risk assessment?

Select the date for the next assessment.

To ensure that risk assessments are conducted regularly and on schedule.
13
How effective is the risk communication process within the organization?

Select the effectiveness level.

To evaluate whether risk-related information is effectively shared among stakeholders.
14
What challenges have you encountered in the risk management process?

Describe any challenges faced.

To identify obstacles that may hinder effective risk management.
15
How many risk mitigation actions have been implemented?

Enter the total number of implemented actions.

To assess the organization's proactive approach to managing risks.
Min: 0
Target: 5
Max: 50
16
When was the last training session on risk management held?

Select the date of the last training.

To ensure that staff are regularly updated on risk management practices.
17
How effective is the current risk monitoring system?

Select the effectiveness level.

To assess the adequacy of the risk monitoring activities in place.
18
Is there a clear incident reporting process in place for risk-related incidents?

Indicate whether an incident reporting process exists.

To ensure that all incidents are reported and addressed promptly.
19
How often are risk reviews conducted (in months)?

Enter the frequency of risk reviews.

To ensure that risk reviews are performed at appropriate intervals.
Min: 1
Target: 6
Max: 12
20
When is the next scheduled training session on risk management?

Select the date for the next training session.

To ensure that ongoing training is provided to staff on risk management practices.

FAQs

The purpose is to guide the evaluation of risks and the implementation of control measures for medical devices.

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

It ensures that risks are thoroughly evaluated and controlled, enhancing device safety.

Benefits include enhanced device safety, effective risk mitigation, and regulatory compliance.

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

Benefits

Facilitates thorough evaluation and control of medical device risks.

Ensures compliance with ISO 14971 standards.

Enhances safety and reliability of medical devices.

Supports effective risk mitigation strategies.

Improves patient protection by addressing risks comprehensively.