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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?
2
What is the date of the latest review of the risk documentation?
3
How often is the risk assessment conducted?
Min: 1
Target: 6
Max: 12
4
Are the medical device records available for review?
5
Is patient information adequately transparent in the risk documentation?
6
Provide a description of the current risk management strategy in place.
7
How many incidents related to risk management have been reported in the last year?
Min: 0
Target: 5
Max: 100
8
When was the risk documentation last updated?
9
How effective are the current risk controls implemented?
10
What is the date when the current risk controls were implemented?
11
How many reviews of risk controls have been conducted in the past year?
Min: 0
Target: 3
Max: 12
12
What lessons have been learned from the implementation of risk controls?
13
Is the incident reporting process compliant with ISO 14971 requirements?
14
What is the average response time for incidents reported?
15
How many incidents have been resolved in the past year?
Min: 0
Target: 20
Max: 100
16
When was the last review of incident reports conducted?
17
How clear is the communication of risks to stakeholders?
18
Provide a summary of stakeholder feedback regarding risk communication.
19
How often is risk communication conducted?
Min: 1
Target: 3
Max: 12
20
When was the last risk communication sent to stakeholders?

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.