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