SBOM for FDA Premarket Submissions for Surgical Robotics
FDA-aligned SBOMs for surgical robotic systems - RT-Linux, ROS/ROS2 stacks, joint-controller firmware, and FPGA bitstreams. VEX included where the manufacturer uses it.
Aligned to FDA's February 3, 2026 premarket cybersecurity guidance.
Surgical robotic SBOMs are difficult because the system is heterogeneous: a RT-Linux compute node running ROS or ROS2, multiple microcontroller-based joint controllers with their own firmware, often FPGAs with proprietary bitstreams, and an integration tower running a separate stack. A single CycloneDX file generated from the main compute node misses 60% of the safety-critical software. Our SBOM service for this segment produces a multi-document SBOM aligned to the system architecture - one document per safety-relevant compute element - with cross-references and an aggregate VEX.
We instrument the build pipeline for the main compute node (Bazel, CMake, Yocto - whatever you use) so the SBOM is build-time accurate, not runtime-inferred. We capture ROS/ROS2 packages, including DDS implementation and security plugins. For joint-controller firmware we work with the toolchain (Keil, IAR, custom) to extract third-party libraries - many are FreeRTOS or vendor-modified - and produce per-MCU SBOMs. FPGA bitstreams are documented at the IP-block level with vendor licensing data. The aggregate is delivered as a CycloneDX 1.5 bundle with explicit sub-components, plus VEX statements that explain why the long tail of Linux CVEs is or is not exploitable on your hardened production image. The SBOM follows the system architecture, not just the main codebase.
Layers we exercise in this engagement
The surgical robotics system, from the outermost cloud and clinician surfaces down to the device itself. Highlighted layers are exercised by this medical device sbom services.
- 01RT Linux kernel Tested
- 02ROS / ROS2 + DDS Tested
- 03EtherCAT / CAN stacks Tested
- 04Vendor middleware Tested
- 05Vision pipeline Tested
- 06Web UI on integration tower Tested
Layers shown outermost (top) to innermost (bottom). Dashed rows are part of the surrounding system but out of scope for this view.
Medical Device SBOM Services engagement, end to end
Four phases, fixed fee, scoped to surgical robotics architecture from kickoff onward.
- 01
Build-pipeline integration
SPDX 2.3 SBOMs generated from your actual build, not from runtime introspection alone.
- 02
Enrichment + triage
Components enriched from NVD, OSV, and GHSA; every CVE above your threshold triaged for exploitability.
- 03
VEX authoring
VEX statements (not_affected, affected, fixed, under_investigation) with documented justifications, where the manufacturer chooses to use VEX.
- 04
Postmarket handoff
SBOM + VEX delivery hooked into your QMS so postmarket monitoring continues after submission.
What we see in Surgical Robotics medical device sbom services
The patterns we hit in this segment, this service, again and again.
Joint-controller firmware components un-inventoried
Main compute node SBOM is clean, but the safety-critical motor controllers ship without any third-party software inventory. FreeRTOS + vendor lib versions undocumented.
DDS implementation and security plugin invisible
ROS2 SBOM lists rclcpp but not the Fast-DDS or Cyclone DDS implementation, and not the security plugin (or its absence). Reviewer cannot evaluate the auth posture from the SBOM.
FPGA bitstream IP unspecified
Bitstream listed as a single binary blob. Vendor and version of motion-control IP cores not captured - material for both security review and regulatory traceability.
Yocto base layers drift between releases
Same product version had different OS package hashes across two manufacturing runs. SBOM not re-generated per build, so deployed CVEs differ from documented ones.
"Blue Goat Cyber takes the burden off our engineers and makes FDA cybersecurity requirements easy to understand. Their expertise and smooth process mean we can focus on our product, not the paperwork. The organized documentation, perfectly formatted for eSTAR, saves us countless hours."
Standard Medical Device SBOM Services deliverables
The same deliverables the parent Medical Device SBOM Services service ships with - tuned to your surgical robotics architecture.
- SPDX and CycloneDX generation
- Component vulnerability mapping (CVE / KEV)
- End-of-life and replacement planning
- Build-system and binary SCA validation
What lands in your eSTAR submission
Documents structured for the cybersecurity attachments of your submission - no reformatting on your side.
- SPDX and CycloneDX generation
- Component vulnerability mapping (CVE / KEV)
- End-of-life and replacement planning
- Build-system and binary SCA validation
Standards that apply
The Surgical Robotics baseline, plus the call-outs that matter for medical device sbom services in this segment.
Segment-specific call-outs
AAMI TIR57 + IEC 81001-5-1
Multi-element SBOMs need an architecture map for reviewers to follow - TIR57 framing helps.
IEC 60601-2-77 (RAS equipment)
For surgical robotics, the SBOM should map to the safety architecture, not just the codebase.
What's not in scope
We scope tightly on purpose. These items are either out-of-scope by design or belong in a separate engagement - we'll tell you up front, not after kickoff.
- Penetration testing of components in the SBOM
- Code refactoring to remove vulnerable dependencies
- License-compliance legal review (we surface, your counsel rules)
Medical Device SBOM Services for Surgical Robotics - FAQs
The questions buyers in this segment actually ask before scoping a medical device sbom services engagement.
Go deeper on Surgical Robotics and premarket
A practical, ungated buyer's guide for medical device manufacturers evaluating cybersecurity partners, what goes wrong, why it costs you, and what to demand from your next engagement. Aligned to the FDA February 2026 premarket guidance.
The most common high- and critical-severity findings we surface in medical device penetration tests, what each one looks like in the field, and how to fix it before your FDA submission.
A practical, ungated guide to the threat modeling gaps that trigger FDA cybersecurity questions in 510(k), De Novo, and PMA submissions - and exactly how to close them before reviewers find them.
Medical device cybersecurity should scale with device risk. Christian Espinosa argues why meeting only the Section 524B minimum leaves patients and submissions exposed.
VEX resources for medical device teams: a document guide, SBOM comparison, and common assessment mistakes, with evidence-based status and regulatory context.
Medical device cybersecurity for nanotech neurostimulation: a fictional STRIDE threat model linking controller risks, patient harms, controls, and testing.
Other engagements for Surgical Robotics
Teams in this segment commonly bundle these alongside medical device sbom services.
Keep going
Scope a Medical Device SBOM Services engagement for your surgical robotics program.
A 30-minute discovery call with Christian Espinosa, Founder and CEO, and Kristy Kennedy, VP of Sales.