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Medical Device Risk Acceptance Checklist

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

Medical Device Risk Acceptance Checklist

by: audit-now
4.4

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About This Checklist

The Medical Device Risk Acceptance Checklist is an essential tool for healthcare organizations aiming to comply with ISO 14971 standards. This checklist aids in the evaluation and acceptance of residual risks associated with medical devices, ensuring that all risks are within acceptable levels before product release. By using this checklist, healthcare providers can enhance device safety, ensure regulatory compliance, and make informed decisions regarding risk acceptance. Keywords: risk acceptance, ISO 14971 compliance, medical device safety, healthcare risk management.

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Industry

Healthcare

Standard

ISO 14971 - Medical Device Risk Management

Workspaces

Hospitals
Clinics
Medical Device Manufacturing Facilities

Occupations

Risk Manager
Compliance Officer
Quality Assurance Specialist
Medical Device Engineer
Healthcare Administrator
1
Does the risk acceptance process comply with ISO 14971 standards?
2
What is the severity rating of the identified risks?
Min: 1
Target: 3
Max: 5
3
What mitigation measures are in place for identified risks?
4
When was the last review of the risk acceptance process conducted?
5
Has the risk acceptance been formally approved?
6
Was the risk management team involved in the risk acceptance process?
7
Provide any additional comments or observations regarding the risk acceptance process.
8
How many risks were assessed during the risk acceptance process?
Min: 0
Target: 0
Max: 100
9
What is the scheduled date for the next review of the risk acceptance process?
10
Has a check been conducted to ensure compliance with relevant regulations?
11
What are the key risks identified during the assessment?
12
Is there documented evidence of risk acceptance?
13
How often are risk assessments conducted?
Min: 1
Target: 12
Max: 12
14
When was the last training conducted for staff on risk management?
15
Have all stakeholders agreed on the risk acceptance decision?
16
What is the justification for accepting the identified risks?
17
What is the estimated impact of the accepted risks on operations?
Min: 1
Target: 0
Max: 10
18
Has the risk acceptance been communicated to all relevant parties?
19
What is the scheduled frequency for reviewing accepted risks?
20
What lessons have been learned from the risk management process?
21
Have historical trends in risk acceptance been analyzed?
22
What is the total number of risks logged in the system?
Min: 0
Target: 0
Max: 500
23
When was the last training session held for staff on risk management?
24
Are there regular updates provided on the status of accepted risks?
25
What future strategies are planned for mitigating risks?

FAQs

The purpose is to guide the evaluation and acceptance of residual risks associated with medical devices.

Healthcare professionals involved in risk management and product release decisions should use this checklist.

It ensures that all risks are evaluated and accepted according to ISO 14971 standards, supporting regulatory compliance.

Benefits include enhanced device safety, informed decision-making, and regulatory compliance.

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

Benefits of Medical Device Risk Acceptance Checklist

Facilitates informed decision-making on risk acceptance.

Ensures compliance with ISO 14971 standards.

Enhances safety and reliability of medical devices.

Supports regulatory compliance and product release decisions.

Improves patient safety by ensuring acceptable risk levels.