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Medical Device Software Validation Audit Checklist

A comprehensive checklist for auditing software validation processes in medical device development, ensuring compliance with ISO 13485 standards and improving overall software quality and safety in healthcare products.

Medical Device Software Validation Audit Checklist

by: audit-now
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About This Checklist

The Medical Device Software Validation Audit Checklist is an essential tool for healthcare organizations to ensure compliance with ISO 13485 standards in software development and validation processes. This comprehensive checklist addresses critical aspects of software lifecycle management, including requirements analysis, design, implementation, testing, and maintenance of software used in medical devices. By implementing rigorous software validation practices, companies can minimize risks associated with software failures, enhance device reliability, and maintain regulatory compliance. This checklist aids in systematically evaluating software development methodologies, verification and validation processes, and change management procedures, ultimately contributing to improved patient safety and software quality in the medical device industry.

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Industry

Healthcare

Standard

ISO 13485 - Medical Device Quality Management

Workspaces

Medical Device Software Development Laboratory

Occupations

Software Engineer
Quality Assurance Specialist
Regulatory Affairs Manager
Software Validation Engineer
Medical Device Software Developer
1
Is the software validation process documented and approved?
2
Has a risk assessment been completed for the software?
3
What percentage of validation tests have been completed?
Min: 0
Target: 100
Max: 100
4
Are there any deviations from the validation protocol?
5
What is the compliance level of the software validation?
6
Has the validation protocol been approved by the designated authority?
7
What was the start date of the validation process?
8
What is the expected completion date for the validation process?
Min: 1
Max: 365
9
Who are the team members involved in the validation process?
10
Has a post-validation review been conducted?
11
Is the test environment configured correctly for validation?
12
Have error logs been reviewed during the validation process?
13
How many test cases were executed during validation?
Min: 1
Target: 100
Max: 1000
14
Provide a summary report of the validation results.
15
Is the software compliant with applicable regulatory standards?

FAQs

The checklist covers areas such as software development planning, requirements management, risk analysis, design and coding standards, verification and validation testing, configuration management, and software maintenance processes.

It includes specific items to verify that proper risk management techniques are applied throughout the software development process, and that thorough testing is conducted to identify and mitigate potential software-related hazards.

The audit should involve software engineers, quality assurance specialists, regulatory affairs professionals, and subject matter experts in medical device software development and validation.

Software validation audits should be performed at key milestones during the development process, before major releases, and periodically (e.g., annually) for marketed devices to ensure ongoing compliance and quality.

Inadequate software validation can lead to device malfunctions, patient harm, regulatory non-compliance, costly recalls, damage to company reputation, and potential legal liabilities.

Benefits of Medical Device Software Validation Audit Checklist

Ensures compliance with ISO 13485 software validation requirements

Reduces risks associated with software failures in medical devices

Improves software quality and reliability throughout the development lifecycle

Enhances traceability between software requirements and implemented features

Facilitates efficient regulatory submissions and approvals