Case Study Details
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