• Preview of QMSREGS ISO 13485 compliant Software Validation and Revalidation Procedure template
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Software Validation Procedure - ISO 13485

Software Validation Procedure - ISO 13485

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Template Overview

Ensure regulatory compliance and software reliability with our ISO 13485:2016 Clause 4.1 Software Validation Procedure Template. Software used in Quality Management Systems (QMS) and medical device development must be validated to ensure its accuracy, reliability, and compliance with ISO 13485:2016, FDA 21 CFR Part 820, MDR, IVDR, and ISO 62304. This structured procedure template provides a step-by-step approach to software validation, ensuring full traceability, risk management, and audit readiness.

Key Features

✔ Pre-Formatted Software Validation Procedure – Covers key ISO 13485:2016 Clause 4.1 requirements.

✔ Software Classification & Risk Assessment – Determine validation scope based on software impact.

✔ Validation Planning & Test Case Development – Define software requirements, acceptance criteria, and test cases.

✔ Verification & Performance Testing Logs – Document test execution results and pass/fail status.

✔ Regulatory Compliance & Risk Management – Align validation with ISO 14971 risk assessment and mitigation strategies.

✔ Change Management & Re-Validation Process – Ensure ongoing compliance with software updates.

✔ Approval & Sign-Off Workflow – Assign responsibilities for validation review and approval.

✔ Editable Digital Format – Fully customizable for various QMS software applications.

Why choose a QMS Template?

This ready-to-use software validation procedure template is ideal for quality managers, software validation teams, and regulatory professionals, ensuring a structured, compliant, and risk-managed approach to software validation.

Download the ISO 13485:2016 Software Validation Procedure Template today and improve your QMS compliance and software reliability!
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Additional information

  • About Patient Guard

    QMSRegs was founded in 2020 by the Patient Guard group to help companies get their medical devices to market and achieve Medical Device compliance. Patient Guard’s consultancy services offers a cost-effective solution for all your Quality Management System needs.

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    For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to provide feedback, contact us at qmsregs@patientguard.com.