Secure Design and Development SOP

This Standard Operating Procedure (SOP) outlines processes for integrating security into the design and development of medical devices. It covers key areas including secure coding practices, threat modeling, secure communications, Software Bill of Materials (SBOM) management, security-focused reviews, and secure configuration management. The SOP emphasizes the importance of incorporating security measures throughout the entire development lifecycle and maintaining comprehensive documentation to ensure the creation of secure medical devices.

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