Case Study Details
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Case Study Information
- Project Name: Device FDA Submission
- Service: Regulatory Submission & Go to Market Support
- Client: Private
- Complete Date: 2020
Performed key cybersecurity activities in preparation for a US FDA submission, for a medical device and medical device data system.
This project was required to support the regulatory submission and approval of a medical device and medical device data systems, as US FDA requires various cybersecurity activities during a submission.
Device FDA Submission
The project involved the following:
- Executing a threat model workshop with key internal stakeholders, which involved a whiteboarding session to document the architecture and overlay threats and areas to protect (assets)
- Developing architecture and data flow diagrams
- Documenting the threat model
- Documenting cybersecurity design input and system level requirements, based on the architecture and key attributes of the solution
- Reviewing static application security testing and software composition analysis test results and supporting the development teams on items requiring remediation
- Performing a product security risk assessment on all identified gaps, utilizing the Common Vulnerability Scoring System (CVSS)
- Supported the preparation of the regulatory submission package to the US FDA
