A medical device company developing connected diagnostic tools required support to secure embedded systems, meet FDA cybersecurity requirements, and monitor deployed devices for vulnerabilities in the field.

Tasks:

  • Perform secure code reviews and threat modeling on embedded software

  • Implement encrypted firmware updates and device authentication

  • Build a Software Bill of Materials (SBOM) for regulatory submission

  • Design postmarket surveillance strategy and alerting

  • Prepare cybersecurity documentation for FDA 510(k)

Skills Involved:

  • Embedded software and firmware security

  • FDA regulatory compliance (pre/postmarket cybersecurity guidance)

  • SBOM creation and vulnerability management

  • Secure cloud-to-device communication

  • Secure product lifecycle (DevSecOps) integration

Discovery & Process Outline:
The MSSP collaborated with product engineering to embed cybersecurity practices into the development pipeline. Threat models were created for device sensors, wireless modules, and cloud connectivity layers. Firmware was hardened with signed updates and device authentication using unique cryptographic keys. A postmarket monitoring dashboard was created to detect and respond to device anomalies. The MSSP led the preparation of all required cybersecurity documentation for FDA regulatory filings.

Outcomes:

  • Approved 510(k) with FDA cybersecurity compliance

  • Real-time visibility across deployed devices in multiple countries

  • Zero unpatched vulnerabilities in the product lifecycle

  • Secure development practices embedded into future product teams