Case Study Details
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
- 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