KomodoSec's FDA 510(k) Compliance Services is a consulting offering that assists medical device manufacturers in meeting the FDA's cybersecurity requirements for 510(k) premarket submissions, as outlined in the FDA's "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" guidance. The service is structured around three main pillars: Threat Modeling and Risk Assessment: - Defining security controls implemented in the device - Identifying and mitigating device-specific threats - Conducting risk assessments - Performing penetration testing for vulnerability identification - Developing security plans eStar Submission Assistance: - Guiding organizations through the FDA eStar submission process - Preparing accurate and complete documentation - Ensuring regulatory compliance throughout the submission Secure Development and Documentation: - Creating a Software Bill of Materials (SBOM) for software traceability - Developing detailed security plans - Preparing all documentation required for eStar submission The service addresses core FDA 510(k) cybersecurity requirement areas including risk assessment, security controls implementation (access controls, encryption, incident response), documentation, and premarket submission content preparation. Ongoing support is provided from initial threat modeling through addressing any FDA deficiency letters.