Single logo
LoginSign Up

Medical Device Risk Identification Checklist

This checklist is designed to assist in the systematic identification of potential risks for medical devices, ensuring compliance with ISO 14971 standards and enhancing device safety.

Medical Device Risk Identification Checklist

by: audit-now
4.5

Get Template

About This Checklist

The Medical Device Risk Identification Checklist is an essential tool for healthcare organizations focused on ISO 14971 compliance. This checklist aids in the systematic identification of potential risks associated with medical devices, ensuring that all hazards are recognized early in the product lifecycle. By using this checklist, healthcare providers can enhance device safety, ensure regulatory compliance, and proactively manage risks. Keywords: risk identification, ISO 14971 compliance, medical device safety, healthcare risk assessment.

Learn more

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 risk assessment process compliant with ISO 14971?
2
What is the severity rating of the identified risks?
Min: 1
Target: 3
Max: 5
3
Describe the identified risks associated with the medical device.
4
What is the current status of risk mitigation actions?
5
When was the most recent risk assessment conducted?
6
How effective are the current risk controls in place?
7
Who is responsible for managing the identified risks?
8
What is the estimated impact of the identified risks on operations?
Min: 0
Target: 1000
Max: 1000000
9
What is the classification of the identified risks?
10
What preventive measures are in place to mitigate the identified risks?
11
Summarize the findings from the latest risk assessment.
12
How frequently are the identified risks monitored?
Min: 1
Target: 6
Max: 12
13
How effectively are the risks communicated to the relevant stakeholders?
14
Who are the members of the risk assessment team?
15
How many risks were identified during the assessment?
Min: 0
Target: 5
Max: 100
16
When is the next review of the risk management plan scheduled?
17
Is the risk documentation complete and up to date?
18
What historical risk issues have occurred in the past?
19
What is the estimated cost for treatment of the identified risks?
Min: 0
Target: 5000
Max: 100000
20
What is the action plan for mitigating identified risks?

FAQs

The purpose is to guide the systematic identification of potential risks associated with medical devices.

Healthcare professionals involved in risk assessment and device safety should use this checklist.

It ensures that potential hazards are identified early, allowing for timely mitigation strategies.

Benefits include enhanced device safety, early risk identification, and improved patient safety.

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

Benefits of Medical Device Risk Identification Checklist

Facilitates early identification of potential risks in medical devices.

Ensures compliance with ISO 14971 standards.

Enhances safety and reliability of medical devices.

Supports proactive risk management and mitigation.

Improves patient safety by addressing hazards early.