Software Validation Report

Ensure the compliance and quality of your medical device software with our Software Validation Report Template based on IEC 62304. This professionally structured and fully customizable template guides you through the validation process, helping you document all aspects of software development and verification, ensuring compliance with international standards and regulatory requirements.

Key Features:

• IEC 62304 Compliant: Aligned with the requirements of IEC 62304: Medical Device Software – Software Life Cycle Processes, this template ensures that your software validation report meets international standards for the safe and effective development of medical device software.
• Structured for All Software Classes: Whether your software falls under Class A, B, or C, this template is adaptable to all risk classes, covering the entire software life cycle, from planning to release and maintenance.
• Detailed Validation Sections: Pre-defined sections for software testing, verification activities, risk management, and results, ensuring that every aspect of the software's functionality, performance, and safety is validated.
• Traceability to Risk Management & Requirements: Ensures alignment with risk management and functional requirements, integrating the validation process with risk control measures as required by ISO 14971.
• Customizable for Standalone or Embedded Software: Suitable for documenting validation of standalone software as a medical device (SaMD) or embedded software within medical devices.

Why Choose This Template?

• International Standards Compliance: The template ensures your software validation activities comply with IEC 62304, giving you confidence in regulatory submissions and product quality.
• Saves Time & Effort: With pre-structured sections for each stage of validation, this template reduces the time and effort required to document your software validation process.
• Adaptable for Any Software Type: Whether your software is part of a larger medical device or a standalone application, this template is flexible enough to accommodate your specific validation needs.
• Audit-Ready Documentation: Prepare organized, transparent, and traceable software validation documentation that is ready for audits or regulatory inspections.

What’s Included?

• Editable Template in Word format: Fully customizable and ready to tailor for your specific software development and validation activities.
• Pre-Structured Sections: All required elements for a complete validation report, including software requirements traceability, verification results, and risk management integration.
• Guidance Notes: Instructions and examples to help you complete each section of the validation report accurately and efficiently.
• Traceability Matrix: A matrix linking software requirements to testing and validation results, ensuring that all software features are validated against intended functionality.

Ensure Compliance with IEC 62304

Our Software Validation Report Template helps you streamline the process of validating your medical device software, ensuring compliance with IEC 62304 and supporting both regulatory submissions and product quality assurance. Whether your software is classified as low, medium, or high risk, this template provides a comprehensive and structured approach to validation.