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Medical Device Risk Review Checklist

This checklist is designed to assist in the periodic review of risk management activities for medical devices, ensuring compliance with ISO 14971 standards and enhancing device safety.

Medical Device Risk Review Checklist

by: audit-now
4.2

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About This Checklist

The Medical Device Risk Review Checklist is a critical resource for healthcare organizations committed to maintaining compliance with ISO 14971 standards. This checklist facilitates the periodic review of risk management activities related to medical devices, ensuring that all potential hazards are continuously assessed and addressed. By employing this checklist, healthcare providers can enhance device safety, ensure ongoing regulatory compliance, and improve patient care outcomes. Keywords: risk review, ISO 14971 compliance, medical device safety, healthcare risk management.

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Industry

Healthcare

Standard

ISO 14971 - Medical Device Risk Management

Workspaces

Hospitals
Medical Device Manufacturing Facilities
Clinics

Occupations

Risk Manager
Medical Device Engineer
Quality Assurance Specialist
Compliance Officer
Healthcare Safety Officer
1
Is the medical device compliant with ISO 14971 standards?
2
What is the calculated risk score for the medical device?
Min: 0
Target: 0
Max: 100
3
What risk mitigation measures have been implemented?
4
How often is the risk assessment conducted?
5
What is the classification of the medical device?
6
When was the last risk management review conducted?
7
How many incidents related to the device have been reported in the last year?
Min: 0
Target: 0
8
What is the status of the risk management plan?
9
What is the name of the medical device being assessed?
10
Is user training for the medical device completed?
11
What is the frequency of audits conducted for this device in months?
Min: 1
Target: 12
Max: 24
12
Is there an incident response plan in place for the medical device?
13
Is there a compliance process for reporting adverse events related to the device?
14
Is the risk assessment documentation complete and up to date?
15
What is the average time taken to address identified risks?
Min: 1
Target: 30
16
Is there an active post-market surveillance plan for the device?
17
What is the name of the manufacturer of the medical device?
18
When was the last compliance audit conducted on the medical device?
19
How many non-conformities were identified during the last audit?
Target: 0
20
What is the regulatory approval status of the medical device?

FAQs

The main objective is to guide the periodic review of risk management activities related to medical devices.

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

It ensures that risk management activities are regularly reviewed and updated, supporting continuous improvement.

Key benefits include enhanced device safety, ongoing regulatory compliance, and improved patient care outcomes.

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

Benefits of Medical Device Risk Review Checklist

Ensures ongoing evaluation of risk management activities.

Supports compliance with ISO 14971 standards.

Enhances safety and reliability of medical devices.

Facilitates continuous improvement in risk management.

Improves patient care outcomes through regular risk assessment.