Software as a Medical Device Submission Templates

This document contains a comprehensive set of templates for software development in a medical device context, covering various aspects such as software description, requirements specification, architecture, risk management, verification and validation, configuration management, design, maintenance, and deployment. Each template provides a structured framework for documenting critical information, processes, and plans throughout the software development lifecycle. These templates are designed to ensure compliance with regulatory standards, maintain software quality, and facilitate effective management of medical device software development projects.

How to use these templates:

• Click on the links to access the templates

  • If you are a Google Workplace organization, make a copy by going to File > Make a copy

  • If you are not a Google Workplace organization, download a copy by going to File > Download and selecting your preferred file type (available as DOCX, PDF, and more)

• Review and then remove instructional text

• Save in a centralized place

• Attach to evidence either through Integrations, Automated Collection, or direct upload