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Medical Device Risk Management Planning Checklist

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

Medical Device Risk Management Planning Checklist

by: audit-now
4.7

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About This Checklist

The Medical Device Risk Management Planning Checklist is a crucial tool for healthcare organizations committed to ISO 14971 compliance. This checklist assists in the development and implementation of comprehensive risk management plans for medical devices, ensuring that all potential risks are systematically identified and addressed. By utilizing this checklist, healthcare providers can enhance device safety, ensure regulatory compliance, and streamline risk management processes. Keywords: risk management planning, ISO 14971 compliance, medical device safety, healthcare risk strategy.

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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 Administrator
1
Is the risk management process compliant with ISO 14971?
2
Is there a documented risk management plan available?
3
How many risks have been identified in the current risk management cycle?
Min: 0
Target: 0
Max: 100
4
How effective are the current risk mitigation measures?
5
Who is part of the risk assessment team?
6
When was the last risk assessment conducted?
7
What categories of risks have been identified?
8
What is the highest severity level of identified risks (1-5)?
Min: 1
Target: 1
Max: 5
9
Is the medical device compliant with safety regulations?
10
Is there a documented process for reporting safety incidents?
11
How many safety incidents have been reported in the past year?
Min: 0
Target: 0
Max: 100
12
How effective is the post-market surveillance for the medical device?
13
Have all staff received training in risk management procedures?
14
How often are risk assessments reviewed?
Min: 1
Target: Annually
Max: 12
15
Is there documentation for the current risk mitigation strategies?
16
How would you rate the effectiveness of the current risk management process?
17
Are there established protocols for ensuring patient safety?
18
When was the last review of the patient safety protocols conducted?
19
How many adverse events have been reported in the past year?
Min: 0
Target: 0
Max: 100
20
How effective is the communication regarding patient safety among staff?

FAQs

The purpose is to guide the development and implementation of risk management plans for medical devices.

Healthcare professionals involved in risk management planning and strategy should use this checklist.

It ensures that risk management plans align with ISO 14971 standards, supporting regulatory compliance.

Benefits include enhanced device safety, systematic risk identification, and improved risk management efficiency.

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

Benefits of Medical Device Risk Management Planning Checklist

Facilitates the development of comprehensive risk management plans.

Ensures compliance with ISO 14971 standards.

Enhances safety and reliability of medical devices.

Supports systematic identification and mitigation of risks.

Improves efficiency and effectiveness of risk management processes.