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ISO 14971 Risk Control Measures Implementation Checklist

A comprehensive checklist designed to guide medical device manufacturers through the process of implementing and verifying risk control measures in accordance with ISO 14971, ensuring effective risk mitigation and enhanced product safety.

ISO 14971 Risk Control Measures Implementation Checklist
by: audit-now
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About This Checklist

The ISO 14971 Risk Control Measures Implementation Checklist is a vital tool for medical device manufacturers and healthcare organizations to ensure effective application of risk mitigation strategies. This checklist guides professionals through the crucial process of implementing and verifying risk control measures as outlined in ISO 14971. By systematically addressing each aspect of risk control, from design modifications to user warnings, this checklist helps organizations minimize potential hazards associated with medical devices. It promotes a proactive approach to risk management, enhancing product safety and regulatory compliance while safeguarding patient well-being.

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Industry

Healthcare

Standard

ISO 14971

Workspaces

Medical Device Design and Manufacturing Facilities

Occupations

Medical Device Engineer
Risk Management Specialist
Quality Assurance Manager
Regulatory Compliance Officer
Product Safety Specialist

Risk Control Measures Assessment

(0 / 4)

1
What is the current status of the risk control measures implementation?

Select the current implementation status.

To track the progress of implementing risk control measures.
2
Is the safety information regarding the medical device readily available?

Provide details about the availability of safety information.

To ensure that safety information is accessible for users and regulatory compliance.
3
What percentage of risk has been reduced by the control measures?

Enter the percentage of risk reduction.

To quantify the effectiveness of risk control measures in percentage.
Min: 0
Target: 50
Max: 100
4
How effective are the implemented risk control measures?

Select the effectiveness level.

To evaluate the effectiveness of risk control measures in mitigating risks associated with medical devices.
5
How many risks were identified during the assessment?

Enter the total number of identified risks.

To quantify the number of risks that have been recognized in the process.
Min: 0
Target: 10
Max: 100
6
When was the last review of the risk control measures conducted?

Select the date of the last review.

To ensure that risk control measures are regularly reviewed and updated.
7
Describe the risk mitigation strategies that have been implemented.

Provide a detailed description of risk mitigation strategies.

To document the specific strategies used to mitigate identified risks.
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8
Are the risk control measures aligned with the ALARP (As Low As Reasonably Practicable) principle?

Select whether the measures adhere to the ALARP principle.

To determine if the risk levels are minimized to the lowest practical extent.
9
When is the next scheduled compliance review for the device?

Select the date for the next compliance review.

To ensure that regular compliance reviews are planned and adhered to.
10
What is the estimated residual risk level after implementing control measures?

Enter the estimated residual risk level.

To quantify the remaining risk associated with the device after mitigation efforts.
Min: 0
Target: 5
Max: 10
11
Is there a documented risk assessment report for the device?

Provide details regarding the risk assessment report.

To verify that a formal risk assessment has been conducted and documented.
12
Is the medical device compliant with relevant regulatory standards?

Select the compliance status.

To ensure that the device meets all necessary regulations for safety and efficacy.
13
When was the last design review conducted?

Select the date of the last design review.

To ensure that design reviews are performed regularly to assess risk management.
14
How many design changes were made to address identified risks?

Enter the total number of design changes.

To quantify the number of changes made in response to risk assessments.
Min: 0
Target: 3
Max: 50
15
Describe the verification activities conducted during the design phase.

Provide a detailed description of the design verification activities.

To document the verification processes that ensure design requirements are met.
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16
How effective is the design control process in identifying and mitigating risks?

Select the effectiveness level of the design control process.

To evaluate the effectiveness of the design control process in risk management.
17
When is the next scheduled review of post-market surveillance data?

Select the date for the next surveillance review.

To ensure that regular reviews are planned to assess ongoing risk management and compliance.
18
What actions have been taken to mitigate risks identified from adverse events?

Provide a detailed description of the mitigation actions taken.

To document the corrective and preventive actions implemented based on post-market surveillance findings.
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19
How many adverse events related to the device have been reported in the last year?

Enter the total number of adverse events reported.

To quantify the number of adverse events for trend analysis and risk assessment.
Min: 0
Target: 15
Max: 100
20
Are adverse events related to the medical device being reported in compliance with regulations?

Select the compliance status for adverse event reporting.

To ensure that all adverse events are reported accurately and timely to regulatory authorities.

FAQs

The primary purpose is to guide the implementation and verification of risk control measures for medical devices, ensuring they effectively mitigate identified risks in compliance with ISO 14971 standards.

This checklist should be used during the design and development phase, as well as throughout the product lifecycle whenever new risks are identified or existing risk controls need to be re-evaluated.

The checklist covers inherent safety by design, protective measures in the medical device or manufacturing process, and information for safety such as warnings and training.

By guiding a systematic review of risk control measures, the checklist helps ensure that risks are reduced to the lowest practical level, supporting the ALARP principle emphasized in ISO 14971.

The checklist should involve a cross-functional team including design engineers, risk management specialists, quality assurance personnel, and clinical experts to ensure comprehensive risk control implementation.

Benefits

Ensures thorough implementation of risk control measures as per ISO 14971

Facilitates systematic verification of risk control effectiveness

Improves traceability between identified risks and implemented controls

Enhances overall product safety and reduces potential for adverse events

Supports regulatory compliance and audit readiness