Single logo
LoginSign Up

Medical Device Risk Evaluation and Control Checklist

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

Medical Device Risk Evaluation and Control Checklist

by: audit-now
4.6

Get Template

About This Checklist

The Medical Device Risk Evaluation and Control Checklist is a comprehensive tool for healthcare organizations dedicated to ISO 14971 compliance. This checklist guides professionals through the evaluation of identified risks and the implementation of appropriate control measures to mitigate them. By utilizing this checklist, healthcare providers can ensure device safety, maintain regulatory compliance, and enhance patient protection. Keywords: risk evaluation, risk control, ISO 14971 compliance, medical device safety.

Learn more

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 risk assessment process compliant with ISO 14971 standards?
2
What is the effectiveness rating of the implemented risk controls (on a scale of 1 to 5)?
Min: 1
Target: 5
Max: 5
3
Please provide a summary of the most recent risk evaluation conducted.
4
What is the current status of the risk management plan?
5
What is the implementation status of the identified risk controls?
6
Please upload the documentation related to the risk assessment.
7
What is the residual risk level after implementing controls (on a scale of 1 to 10)?
Min: 1
Target: 3
Max: 10
8
When was the last review of the risk management process conducted?
9
How effective is the current risk identification process?
10
Have all relevant personnel received training on risk management procedures?
11
How many risks were identified in the last risk assessment?
Min: 0
Target: 10
Max: 100
12
When is the next scheduled risk assessment?
13
How effective is the risk communication process within the organization?
14
What challenges have you encountered in the risk management process?
15
How many risk mitigation actions have been implemented?
Min: 0
Target: 5
Max: 50
16
When was the last training session on risk management held?
17
How effective is the current risk monitoring system?
18
Is there a clear incident reporting process in place for risk-related incidents?
19
How often are risk reviews conducted (in months)?
Min: 1
Target: 6
Max: 12
20
When is the next scheduled training session on risk management?

FAQs

The purpose is to guide the evaluation of risks and the implementation of control measures for medical devices.

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

It ensures that risks are thoroughly evaluated and controlled, enhancing device safety.

Benefits include enhanced device safety, effective risk mitigation, and regulatory compliance.

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

Benefits of Medical Device Risk Evaluation and Control Checklist

Facilitates thorough evaluation and control of medical device risks.

Ensures compliance with ISO 14971 standards.

Enhances safety and reliability of medical devices.

Supports effective risk mitigation strategies.

Improves patient protection by addressing risks comprehensively.