Risk Management SOP

This Standard Operating Procedure (SOP) outlines the processes for identifying, assessing, and mitigating cybersecurity risks associated with medical devices throughout their lifecycle. It details the responsibilities of key personnel and provides a structured approach to risk management, including conducting risk assessments, developing and implementing mitigation strategies, and ongoing monitoring and review of risks. The SOP emphasizes the importance of documentation and regular reporting, ensuring a comprehensive and continuous risk management process for medical device cybersecurity.

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