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Medical Device Risk Mitigation Checklist

This checklist is designed to assist in the implementation of risk mitigation strategies for medical devices, ensuring compliance with ISO 14971 standards and enhancing device safety.

Medical Device Risk Mitigation Checklist
by: audit-now
4.6

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About This Checklist

The Medical Device Risk Mitigation Checklist is an essential tool for healthcare organizations focused on adhering to ISO 14971 standards. This checklist provides a structured approach to identifying and implementing strategies to mitigate risks associated with medical devices. By using this checklist, healthcare providers can enhance device safety, ensure regulatory compliance, and protect patient health. Keywords: risk mitigation, ISO 14971 compliance, medical device safety, healthcare risk management.

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Industry

Healthcare

Standard

ISO 14971

Workspaces

Hospital
Medical Device Manufacturing Facility
Healthcare Clinic

Occupations

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

Risk Mitigation Strategies

(0 / 5)

1
Please provide the details of the risk management plan.

Detail the risk management plan.

To evaluate the comprehensiveness of the risk management strategy.
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2
What is the current status of mitigation actions?

Select the action status.

To track the progress of risk mitigation efforts.
3
What are the identified risks associated with the medical devices?

List all identified risks.

To document and analyze the risks for better management.
4
What is the effectiveness score of the current risk mitigation strategies?

Provide a score from 1 to 5.

To quantify the effectiveness of risk mitigation efforts.
Min: 1
Target: 4
Max: 5
5
Is the risk assessment process compliant with ISO 14971?

Select compliance status.

To ensure that the organization follows the required standards for risk management.
6
Describe how stakeholders are involved in the risk management process.

Detail stakeholder involvement.

To assess the level of collaboration and input from relevant parties.
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7
How frequently are risks reviewed and updated?

Select the review frequency.

To ensure that risk assessments are kept current.
8
What strategies are in place for mitigating identified risks?

Describe the mitigation strategies.

To understand the strategies employed to manage risks effectively.
9
How many risks have been documented in the last assessment?

Enter the number of documented risks.

To evaluate the thoroughness of the risk assessment process.
Min: 0
Target: 10
Max: 100
10
Is there a formal process for identifying risks in medical devices?

Select the applicable status.

To ensure a systematic approach to risk identification is in place.
11
Describe the risk communication plan for informing stakeholders.

Detail the risk communication strategy.

To ensure effective communication regarding risks associated with medical devices.
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12
How often is post-market surveillance conducted for medical devices?

Select the frequency of post-market surveillance.

To ensure ongoing monitoring of medical device safety in the market.
13
What corrective actions have been implemented following incidents?

Provide details of corrective actions.

To evaluate the effectiveness of responses to safety incidents.
14
How many safety incidents have been reported in the last year?

Enter the number of reported incidents.

To assess the safety performance and identify areas for improvement.
Min: 0
Target: 5
Max: 100
15
Are all medical devices subjected to required safety testing?

Select compliance status.

To confirm adherence to safety testing regulations for medical devices.
16
Provide details on how risk mitigation strategies are evaluated for effectiveness.

Detail the evaluation process for risk mitigation strategies.

To ensure that mitigation strategies are assessed and improved over time.
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17
How often is the risk management plan reviewed by stakeholders?

Select the review frequency.

To ensure that stakeholder input is regularly incorporated into the risk management process.
18
How are risk management activities documented?

Describe the documentation process.

To ensure that there is a clear record of risk management efforts.
19
How many training sessions on risk management have been conducted in the past year?

Enter the number of training sessions.

To assess the organization's commitment to risk management training.
Min: 0
Target: 8
Max: 50
20
Is there a standardized methodology for conducting risk assessments?

Select the applicable status.

To verify that a consistent approach is used for assessing risks.
21
How are staff trained on patient safety protocols?

Detail the training programs on patient safety.

To assess the effectiveness of training programs in promoting patient safety.
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22
How often are patient safety audits conducted?

Select the frequency of audits.

To ensure regular evaluation of patient safety practices.
23
Describe the process for conducting root cause analysis of incidents.

Detail the root cause analysis process.

To ensure that incidents are thoroughly analyzed to prevent recurrence.
24
What is the average response time to reported incidents (in hours)?

Enter the average response time in hours.

To evaluate the efficiency of the response to patient safety incidents.
Min: 0
Target: 2
Max: 24
25
Is there an effective incident reporting system in place for patient safety?

Select the applicable status.

To ensure that incidents are reported and addressed promptly.

FAQs

The purpose is to guide the implementation of strategies to mitigate risks associated with medical devices.

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

It ensures that effective risk mitigation strategies are implemented, reducing potential hazards.

Benefits include enhanced device safety, regulatory compliance, and proactive risk management.

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

Benefits

Facilitates effective risk mitigation strategies for medical devices.

Ensures compliance with ISO 14971 standards.

Enhances safety and reliability of medical devices.

Supports proactive risk management and reduction.

Improves patient safety by addressing potential hazards.