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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 - Medical Device Risk Management

Workspaces

Medical Device Manufacturing Facilities

Occupations

Medical Device Engineer
Risk Management Specialist
Quality Assurance Manager
Regulatory Compliance Officer
Product Safety Specialist
1
How effective are the implemented risk control measures?
2
What percentage of risk has been reduced by the control measures?
Min: 0
Target: 50
Max: 100
3
Is the safety information regarding the medical device readily available?
4
What is the current status of the risk control measures implementation?
5
Are the risk control measures aligned with the ALARP (As Low As Reasonably Practicable) principle?
6
Describe the risk mitigation strategies that have been implemented.
7
When was the last review of the risk control measures conducted?
8
How many risks were identified during the assessment?
Min: 0
Target: 10
Max: 100
9
Is the medical device compliant with relevant regulatory standards?
10
Is there a documented risk assessment report for the device?
11
What is the estimated residual risk level after implementing control measures?
Min: 0
Target: 5
Max: 10
12
When is the next scheduled compliance review for the device?
13
How effective is the design control process in identifying and mitigating risks?
14
Describe the verification activities conducted during the design phase.
15
How many design changes were made to address identified risks?
Min: 0
Target: 3
Max: 50
16
When was the last design review conducted?
17
Are adverse events related to the medical device being reported in compliance with regulations?
18
How many adverse events related to the device have been reported in the last year?
Min: 0
Target: 15
Max: 100
19
What actions have been taken to mitigate risks identified from adverse events?
20
When is the next scheduled review of post-market surveillance data?

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 of ISO 14971 Risk Control Measures Implementation Checklist

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