Software Verification and Validation Protocol Template and Guide for Medical Devices

Streamline Compliance with Comprehensive V&V Protocols

Ensure your medical device software meets global regulatory standards with our Software Verification and Validation (V&V) Protocol Template and Guide. Designed to support compliance with FDA, EU MDR, and other international regulations, this resource empowers developers and regulatory professionals to efficiently validate their software.

Key Features:

• Structured and Customizable Template: Built with industry-leading standards (FDA, IEC 62304, IEC 82304), ensuring seamless regulatory submission preparation.

• Guidance for Best Practices: Detailed instructions for typical test activities, documenting testing activities, capturing evidence, and managing protocol deviations. It includes a framework and structure for building test cases. We even include a few examples. 

• Regulatory Alignment: Supports off-the-shelf software validation and addresses cybersecurity requirements as per FDA guidance.

Who is it for?

This template is perfect for medical device manufacturers, SaMD developers, and quality assurance teams looking to streamline their software validation processes while ensuring compliance with stringent regulatory requirements.

Why Choose This Template?

Save time, reduce errors, and focus on innovation by leveraging our pre-built, professionally crafted template. Whether you’re developing a new device or updating existing software, this guide will help you stay organized and compliant.

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