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Medical Device Risk Documentation Checklist

This checklist is designed to ensure thorough documentation of risk management activities for medical devices, ensuring compliance with ISO 14971 standards.

Medical Device Risk Documentation Checklist

by: audit-now
4.6

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About This Checklist

The Medical Device Risk Documentation Checklist is an indispensable tool for healthcare organizations striving to comply with ISO 14971 standards. This checklist ensures that all risk management activities related to medical devices are thoroughly documented, providing a clear and comprehensive record for regulatory compliance and internal review. By using this checklist, healthcare providers can enhance transparency, improve accountability, and ensure the integrity of their risk management processes. Keywords: risk documentation, ISO 14971 compliance, medical device records, healthcare transparency.

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Industry

Healthcare

Standard

ISO 14971 - Medical Device Risk Management

Workspaces

Hospitals
Clinics
Medical Device Manufacturing Facilities

Occupations

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

Select compliance status.

To ensure that all risk documentation meets the required standards for medical devices.
2
What is the date of the latest review of the risk documentation?

Enter the date in YYYY-MM-DD format.

To track the recency of the risk documentation review process.
3
How often is the risk assessment conducted?

Enter the frequency in months.

To ensure that risk assessments are conducted regularly as per ISO 14971 requirements.
Min: 1
Target: 6
Max: 12
4
Are the medical device records available for review?

Select the availability status.

To verify the accessibility of medical device records for compliance checks.
5
Is patient information adequately transparent in the risk documentation?

Select transparency status.

To ensure that patient information is clearly communicated and accessible in accordance with healthcare transparency regulations.
6
Provide a description of the current risk management strategy in place.

Describe the risk management strategy in detail.

To evaluate the effectiveness and clarity of the risk management strategy utilized within the organization.
7
How many incidents related to risk management have been reported in the last year?

Enter the number of incidents.

To assess the frequency of risk-related incidents and improve management practices.
Min: 0
Target: 5
Max: 100
8
When was the risk documentation last updated?

Select the date of the last update.

To ensure that the risk documentation is current and reflects the latest information.
9
How effective are the current risk controls implemented?

Select the effectiveness level.

To assess the adequacy and performance of risk controls in mitigating identified risks.
10
What is the date when the current risk controls were implemented?

Enter the implementation date in YYYY-MM-DD format.

To track the implementation timeline of risk controls and their review schedule.
11
How many reviews of risk controls have been conducted in the past year?

Enter the number of reviews conducted.

To evaluate the frequency of reviews and ensure ongoing effectiveness of risk controls.
Min: 0
Target: 3
Max: 12
12
What lessons have been learned from the implementation of risk controls?

Provide a summary of lessons learned.

To capture insights gained from risk management practices that can improve future strategies.
13
Is the incident reporting process compliant with ISO 14971 requirements?

Select compliance status.

To ensure that all incidents are reported in accordance with established standards.
14
What is the average response time for incidents reported?

Enter the average response time in hours.

To evaluate the responsiveness of the incident management system.
15
How many incidents have been resolved in the past year?

Enter the total number of incidents resolved.

To assess the effectiveness of the incident management process.
Min: 0
Target: 20
Max: 100
16
When was the last review of incident reports conducted?

Select the date of the last incident review.

To ensure that incident reports are regularly reviewed for continuous improvement.
17
How clear is the communication of risks to stakeholders?

Select the clarity level.

To evaluate the effectiveness of risk communication strategies and ensure stakeholders understand potential risks.
18
Provide a summary of stakeholder feedback regarding risk communication.

Summarize the feedback received from stakeholders.

To gather insights on how the risk communication is perceived by stakeholders.
19
How often is risk communication conducted?

Enter the frequency of communications in months.

To ensure that risk communication occurs regularly and is part of ongoing management practices.
Min: 1
Target: 3
Max: 12
20
When was the last risk communication sent to stakeholders?

Select the date of the last communication.

To ensure timely communication of risks and updates.

FAQs

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

The purpose is to ensure thorough documentation of all risk management activities related to medical devices.

Healthcare professionals responsible for risk management documentation should use this checklist.

It provides a clear and comprehensive record of risk management activities, supporting regulatory compliance.

Benefits include enhanced transparency, improved accountability, and facilitation of regulatory audits.

Benefits of Medical Device Risk Documentation Checklist

Ensures comprehensive documentation of risk management activities.

Supports compliance with ISO 14971 standards.

Enhances transparency and accountability in risk management.

Facilitates regulatory audits and internal reviews.

Improves the integrity and reliability of risk management processes.