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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?

Select the validation status.

To ensure compliance with ISO 13485 requirements for documentation and approval.
2
Has a risk assessment been completed for the software?

Indicate whether the risk assessment is completed.

To verify that risk management practices are followed.
3
What percentage of validation tests have been completed?

Enter the percentage of tests completed.

To assess the thoroughness of the validation process.
Min: 0
Target: 100
Max: 100
4
Are there any deviations from the validation protocol?

If yes, please describe the deviations.

To identify any non-conformities in the validation process.
5
What is the compliance level of the software validation?

Select the compliance level.

To evaluate adherence to regulatory standards.
6
Has the validation protocol been approved by the designated authority?

Select the approval status of the validation protocol.

To ensure that all validation activities are authorized according to regulatory requirements.
7
What was the start date of the validation process?

Enter the date when validation started.

To track the timeline of validation activities.
8
What is the expected completion date for the validation process?

Enter the expected number of days to complete validation.

To ensure timely completion of validation activities.
Min: 1
Max: 365
9
Who are the team members involved in the validation process?

List the names and roles of team members involved.

To identify personnel responsible for validation activities.
10
Has a post-validation review been conducted?

Select the status of the post-validation review.

To confirm that a review of validation outcomes has taken place.
11
Is the test environment configured correctly for validation?

Select the status of the test environment.

To ensure that the validation is conducted in a suitable and controlled environment.
12
Have error logs been reviewed during the validation process?

Provide details on the error logs review.

To capture any inconsistencies or issues that may arise during testing.
13
How many test cases were executed during validation?

Enter the total number of executed test cases.

To quantify the extent of testing performed.
Min: 1
Target: 100
Max: 1000
14
Provide a summary report of the validation results.

Summarize the validation results, including any issues found.

To document the outcomes and findings of the validation process comprehensively.
15
Is the software compliant with applicable regulatory standards?

Select the compliance status.

To ensure adherence to necessary legal and regulatory requirements.

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