Case Study Details
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Case Study Information
- Project Name: SaMD FDA Submission
- Service: Regulatory Submission & Go to Market Support
- Client: Private
- Complete Date: 2019
Performed key cybersecurity activities in preparation for a US FDA submission, for a machine learning based Software as a Medical Device solution being developed by a startup Medtech company.
This project was required to support the regulatory submission and approval of a software as a medical device solution, as US FDA requires various cybersecurity activities during a submission.
SaMD FDA Submission
The project involved the following:
- Developing architecture and data flow diagrams
- Executing a threat model, which involved overlaying threats and areas to protect (assets) on the architecture diagrams
- 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
