Product Cybersecurity

FDA's December 2023 final guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" established binding expectations for cybersecurity in virtually all network-capable devices.

The Consolidated Appropriations Act of 2023 (Section 524B) gave FDA statutory authority to refuse acceptance of premarket submissions lacking cybersecurity documentation — making compliance non-negotiable.

Software Quality Guru helps medical device manufacturers build cybersecurity programs that satisfy FDA premarket and postmarket requirements, IMDRF principles, and IEC 81001-5-1 for health software security.

Threat modeling is the systematic process of identifying how an adversary could attack your device and what harm could result. We apply STRIDE, PASTA, and attack tree methodologies adapted for medical device contexts.

Our threat modeling engagements produce: system architecture diagrams with trust boundaries, threat enumeration and likelihood/impact scoring, security control gap analysis, and a prioritized risk treatment plan.

For connected devices, we analyze all network interfaces — Bluetooth, Wi-Fi, cellular, USB, NFC, cloud APIs — and assess both the device itself and its ecosystem (mobile apps, cloud backend, hospital network integration).

A Software Bill of Materials (SBOM) is now required in FDA premarket submissions for virtually all software-containing devices. FDA expects manufacturers to identify all software components, including open-source libraries, and demonstrate ongoing vulnerability monitoring.

We help clients: generate and maintain SBOMs in CycloneDX or SPDX formats, establish third-party library management (TPLM) processes, integrate CVE monitoring into your postmarket surveillance system, and document your SBOM management process in your QMS.

We also support security testing requirements including static analysis (SAST), dynamic analysis (DAST), penetration testing coordination, and security-focused code review.

FDA expects manufacturers to monitor cybersecurity vulnerabilities in distributed devices throughout the product lifecycle. This requires documented processes for vulnerability detection, triage, and coordinated disclosure.

We design and implement postmarket cybersecurity programs including: vulnerability monitoring workflows, CVSS scoring and prioritization procedures, coordinated vulnerability disclosure (CVD) policies aligned to ISO 29147, and patch/update deployment procedures.

For manufacturers with existing QMS infrastructure, we integrate cybersecurity surveillance into your existing CAPA and complaint handling processes — avoiding siloed systems that create audit gaps.