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Medical Device Risk Management Audit Checklist

A comprehensive checklist for auditing risk management processes in medical device development and production, ensuring compliance with ISO 13485 and ISO 14971 standards and improving overall product safety and effectiveness.

Medical Device Risk Management Audit Checklist

by: audit-now
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About This Checklist

The Medical Device Risk Management Audit Checklist is an indispensable tool for healthcare organizations to ensure compliance with ISO 13485 and ISO 14971 standards in risk management processes. This comprehensive checklist addresses crucial aspects of identifying, analyzing, evaluating, and controlling risks associated with medical devices throughout their lifecycle. By implementing robust risk management practices, manufacturers can enhance product safety, improve device reliability, and maintain regulatory compliance. This checklist aids in systematically evaluating risk assessment methodologies, risk control measures, and ongoing risk monitoring activities, ultimately contributing to improved patient safety and reduced potential for harm in the healthcare industry.

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Industry

Healthcare

Standard

ISO 13485 - Medical Device Quality Management

Workspaces

Medical Device Manufacturing Facilities

Occupations

Risk Management Specialist
Quality Assurance Manager
Design Engineer
Clinical Affairs Specialist
Regulatory Affairs Manager
1
Is there a documented process for hazard identification related to medical devices?
2
How often is risk analysis conducted for medical devices?
3
Are appropriate risk control measures implemented for identified risks?
4
Is there a process in place to evaluate the impact of risks on patient safety?
5
Is the risk management plan for the medical device readily available and up to date?
6
Are all risk assessments documented appropriately?
7
Are there training records available for personnel involved in risk management processes?
8
Is there a periodic review of risk management records conducted?
9
Is risk management integrated into the product development lifecycle?
10
Are the implemented risk control measures effective in mitigating identified risks?

1

2

3

4

5

11
Is there documented evidence of risk control plans for each identified risk?
12
Are risks communicated effectively to all relevant stakeholders?
13
Is the risk management process compliant with ISO 13485 and ISO 14971 standards?
14
Are regular audits of the risk management process conducted?
15
Are there documented corrective actions taken for any identified non-compliance issues?
16
Do all employees involved in risk management receive proper training?
17
Are the objectives of the risk management process clearly defined and communicated?
18
Is there a documented methodology for conducting risk assessments?
19
Are relevant stakeholders involved in the risk management process?
20
Is there a process in place to monitor identified risks over time?

FAQs

The checklist covers areas such as risk management planning, risk analysis techniques, risk evaluation criteria, risk control option analysis, residual risk assessment, risk management reporting, and post-production information handling.

It includes specific items to verify that all potential risks are identified, properly assessed, and effectively mitigated throughout the device lifecycle, from design and development to post-market surveillance.

The audit should involve cross-functional teams including risk management specialists, design engineers, clinical experts, quality assurance personnel, and regulatory affairs professionals to ensure a holistic approach to risk management.

Risk management audits should be performed at key milestones during product development, before major design changes, and at least annually for marketed devices to ensure ongoing effectiveness of risk control measures.

Inadequate risk management can lead to unforeseen device failures, patient injuries, product recalls, regulatory non-compliance, reputational damage, and significant financial losses for the manufacturer.

Benefits of Medical Device Risk Management Audit Checklist

Ensures compliance with ISO 13485 and ISO 14971 risk management requirements

Reduces potential for device-related adverse events and patient harm

Improves product design and performance through proactive risk mitigation

Enhances decision-making processes in medical device development and production

Facilitates regulatory approvals by demonstrating comprehensive risk management