Medical device cybersecurity, answered.

Blue Goat Cyber specializes in medical device cybersecurity, offering tailored solutions for premarket and postmarket compliance, vulnerability mitigation, and patient safety.

Founder Christian Espinosa named the company after his experiences as an avid mountain climber. Mountain goats represent resilience, focus, and determination. Blue symbolizes trust, clarity, and limitless potential.

We exclusively serve medical device manufacturers - startups, mid-sized companies, and global leaders - across the full product lifecycle.

We stand by our work with a 100% success guarantee. If your submission is delayed due to a cybersecurity deficiency, we resolve it at no additional cost until approved.

Unlike general cybersecurity firms, we focus solely on medical devices. Deep fluency with the FDA's 2026 premarket cybersecurity guidance, ANSI/AAMI SW96, ISO 13485, and ISO 14971 drives every engagement.

IVD and diagnostics, wearables, implantables, robotic surgical systems, SaMD, and legacy devices requiring updated cybersecurity measures.

CISSP, CSSLP, OSCP, CRTE, CARTP, and others - with experience spanning medical device cybersecurity, military cyber operations, and government red team testing.

Our team has contributed cybersecurity documentation, threat models, SBOMs, and pen test reports to 250+ FDA submissions across 510(k), De Novo, and PMA pathways. See the /proof page for the breakdown.

Yes. We routinely sign mutual NDAs, MSAs, and BAAs prior to receiving any device, source code, or PHI. Most NDAs are turned around in under 48 hours.

Section 524B of the FD&C Act (added by the Omnibus 2023 act) requires premarket submissions for 'cyber devices' to include a Secure Product Development Framework (SPDF), a Software Bill of Materials (SBOM), and evidence of vulnerability monitoring and patching. It applies to any device with software that can connect to the internet or another device.

The 2026 final guidance replaces the 2023 version and clarifies expectations around SPDF artifacts, threat modeling rigor, SBOM machine-readability (SPDX or CycloneDX), and the level of evidence reviewers expect for security risk management. Submissions filed after that date are reviewed against the new bar.

An SPDF is a documented set of processes that integrates security across the product lifecycle - design inputs, threat modeling, secure coding, verification, release, and postmarket monitoring. The FDA expects evidence that the SPDF is followed, not just that it exists.

No - cybersecurity artifacts are embedded inside the eSTAR template. We deliver SBOM, threat model, security risk assessment, architecture views, and pen test report in formats that drop directly into the relevant eSTAR sections.

The FDA accepts machine-readable SBOMs in SPDX 2.3+ or CycloneDX 1.4+ formats. We typically deliver CycloneDX 1.5 with VEX statements so reviewers can see which CVEs are exploitable in your device's context.

Yes. For embedded and RTOS-based devices we combine binary analysis (e.g., Binwalk, Ghidra-assisted extraction) with build-time SCA to produce a complete SBOM, including third-party libraries, bootloaders, and OS components.

We issue VEX (Vulnerability Exploitability eXchange) statements indicating whether each CVE is exploitable, under investigation, or not affected. This is the FDA-preferred way to manage the noise from continuous vulnerability scanning.

We default to STRIDE-per-element with attack trees for high-risk flows, aligned to AAMI TIR57 and the FDA's 2026 guidance. For complex SaMD or connected ecosystems we layer in PASTA or LINDDUN (privacy) where appropriate.

Manual exploitation against the device interfaces (USB, serial, JTAG, BLE, Wi-Fi, cellular), companion apps (iOS/Android), cloud APIs and back-end, firmware extraction and reverse engineering, and the surrounding infrastructure - mapped to your threat model.

No. The FDA explicitly expects manual, exploit-driven testing by qualified humans. Automated scans (Nessus, Burp Active Scan, etc.) are part of our toolkit but never the deliverable on their own.

Yes. Every premarket pen test includes one round of remediation retest at no additional cost so your final report shows resolved findings - what reviewers want to see.

Continuous SBOM/CVE monitoring with VEX, a coordinated vulnerability disclosure (CVD) policy, a defined patch validation cadence, and pre-built templates for FDA reportable event communications and customer advisories.

Yes. We perform a gap assessment against current FDA expectations, build a remediation roadmap, generate the missing artifacts (SBOM, threat model, security risk assessment), and harden the device or compensate via mitigations where redesign isn't feasible.

Our deliverables map to EU MDR Annex I GSPR 17.2, MDCG 2019-16, IEC 81001-5-1, and the upcoming EU Cyber Resilience Act essential requirements. One engagement typically satisfies FDA, EU, Health Canada, TGA, and PMDA expectations.

Yes. We address model-specific risks (data poisoning, model inversion, adversarial inputs, prompt injection for LLM-based features) alongside traditional device security, aligned with the FDA's PCCP and AI/ML guidance.

Penetration testing, SBOM management, threat tree development, SAST, secure design consulting, and FDA deficiency response.

It identifies vulnerabilities in software, hardware, and networks, ensuring your device meets FDA cybersecurity requirements and is resilient to real threats.

SBOM management tracks vulnerabilities in third-party and open-source software, aligning with the FDA's 2026 premarket guidance and ANSI/AAMI SW96 supply chain expectations.

Rapid analysis, targeted remediation, updated documentation, and resubmission strategy - most deficiencies closed on first resubmission.

We typically deliver a complete deficiency response package within 2–4 weeks of receiving the letter and source materials, depending on scope. Rush engagements (under 2 weeks) are available.

Real-time threat monitoring, patch management, incident response, and legacy device security to keep your devices compliant after approval.

Threats evolve after FDA clearance. Postmarket cybersecurity ensures ongoing compliance, protects patient safety, and safeguards your devices throughout their lifecycle.

Yes - we align with international standards including ISO 13485, ISO 14971, ANSI/AAMI SW96, IEC 81001-5-1, EU MDR, Health Canada, TGA, PMDA, and IMDRF guidance.

Schedule a free 30-minute Discovery Session. We assess your needs and create a tailored strategy.

Transparent, fixed-fee pricing based on device complexity and scope. No surprises - you can budget confidently.

Most premarket projects (penetration testing, documentation) complete within 4–8 weeks.

We typically begin engagements within 1–2 weeks of contract signature, depending on scope.

All testing and documentation is performed by Blue Goat Cyber W-2 employees and vetted long-term partners under our direct supervision. We never offshore deliverables to anonymous contractors.

Source code, firmware, and devices are handled in isolated, encrypted environments with access limited to the named engineers on your engagement. All artifacts are destroyed or returned at project close per your data handling requirements.

Yes. We routinely operate as an external supplier under ISO 13485 QMS arrangements, complete supplier qualification questionnaires, and provide objective evidence for audits.