Software Verification and Validation Report Template and Guide for Medical Devices

Simplify Compliance with Ready-to-Use V&V Report Templates

Effortlessly document and report your software verification and validation (V&V) activities with our Software Verification and Validation Report Template and Guide for Medical Devices. Designed to align with global regulatory requirements, this template ensures your V&V reports are professional, comprehensive, and audit-ready.

Key Features:

• Protocol Alignment: This goes hand in hand with our plan and protocol template that you can also purchase and download from our store. 

• Regulatory Compliance Focus: Tailored to meet FDA, EU MDR, IEC 62304, and other international standards for medical device software.

• Customizable Framework: Includes pre-structured sections for documenting common software tests (i.e unit tests, system integration, validation results, and more).

• Clear Guidance: Step-by-step instructions for drafting complete and accurate V&V reports, including best practices for capturing evidence and addressing deviations.

Who is it for?

This template is ideal for medical device manufacturers, software developers, and quality/regulatory teams aiming to produce high-quality V&V reports without the hassle of starting from scratch.

Why Choose This Template?

Save time, ensure compliance, and reduce errors with a robust, professionally crafted template that simplifies the reporting process. Whether you’re validating a new software product or updating an existing one, this guide has you covered.

All templates are sold as-is, without any warranties or guarantees of functionality, compatibility, or fitness for a particular purpose. By purchasing, you acknowledge that modifications may be required to suit your specific needs. No refunds, exchanges, or customizations are provided. If you have any issues, feel free to reach out for general guidance, but support is not guaranteed