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Medical Device Risk Monitoring Checklist

This checklist is designed to assist in the continuous monitoring of risks associated with medical devices, ensuring compliance with ISO 14971 standards and enhancing device safety.

Medical Device Risk Monitoring Checklist

by: audit-now
4.2

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About This Checklist

The Medical Device Risk Monitoring Checklist is a critical tool for healthcare organizations dedicated to maintaining compliance with ISO 14971 standards. This checklist aids in the continuous monitoring of risks associated with medical devices, ensuring that any changes in risk levels are promptly identified and addressed. By implementing this checklist, healthcare providers can enhance device safety, ensure ongoing regulatory compliance, and improve patient outcomes. Keywords: risk monitoring, ISO 14971 compliance, medical device safety, continuous risk assessment.

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Industry

Healthcare

Standard

ISO 14971 - Medical Device Risk Management

Workspaces

Hospitals
Clinics
Medical Device Manufacturing Facilities

Occupations

Risk Manager
Medical Device Engineer
Quality Assurance Specialist
Compliance Officer
Healthcare Safety Officer
1
Is the medical device in compliance with ISO 14971 standards?
2
What is the frequency (in days) of risk assessments conducted for the device?
Min: 1
Target: 30
Max: 365
3
Is continuous risk monitoring implemented for the medical device?
4
What are the comments or observations regarding the current risk monitoring process?
5
How effective are the risk control measures currently in place?
6
How many incidents related to the medical device have been reported in the past year?
Min: 0
Target: 0
Max: 100
7
What was the date of the last risk assessment conducted for the device?
8
What recommendations do you have for improving the risk monitoring process?
9
What is the current status of risk mitigation actions for the medical device?
10
What is the total number of risks identified for the medical device?
Min: 0
Target: 5
Max: 100
11
Is there a mechanism in place for users to provide feedback on device safety?
12
What challenges do you face in the current risk monitoring process?
13
Are all staff members trained in risk management practices for the medical device?
14
What is the average response time (in hours) to identified risks?
Min: 1
Target: 24
Max: 72
15
When is the next scheduled review of the risk management plan?
16
What lessons have been learned from past incidents related to the medical device?
17
What is the priority level assigned to the identified risks?
18
How many risk control measures have been implemented to date?
Min: 0
Target: 10
Max: 50
19
Is there an incident reporting system in place for the medical device?
20
What feedback have stakeholders provided regarding the risk management process?

FAQs

The main objective is to guide the continuous monitoring of risks associated with medical devices.

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

It ensures that changes in risk levels are promptly identified and addressed, supporting proactive management.

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

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

Benefits of Medical Device Risk Monitoring Checklist

Facilitates continuous monitoring of medical device risks.

Ensures ongoing compliance with ISO 14971 standards.

Enhances safety and reliability of medical devices.

Supports proactive risk management and mitigation.

Improves patient outcomes through vigilant risk monitoring.