Securing medical devices since 2022. A track record across every major FDA cybersecurity shift - 275+ FDA submissions supported, zero cybersecurity rejections, the standards we map to, the certifications we hold, redacted deliverables you can review, and the press, podcasts, and clients who've vouched for us.
Last updated: Nov 2026 · Self-reported
Competitors quote round numbers. We quote what's actually in the binder. Every entry below comes from a real FDA submission we supported between 2019 and today.
0 cybersecurity-related RTAs or AI-Rs across these submissions, as of this update. Numbers refresh quarterly.
A track record focused exclusively on medical device cybersecurity. Our methodology, templates, and review playbooks have been refined through every major FDA cybersecurity shift - draft guidance, the PATCH Act, Section 524B, the September 2023 premarket guidance, QMSR modernization, the June 2025 interim final guidance, and the Feb 3, 2026 final premarket guidance. When the rules change, our deliverables already match.
Began securing connected medical devices when 'MedTech cybersecurity' was barely a category. Built our first FDA premarket cyber packages.
Adapted our methodology to FDA's draft premarket cybersecurity guidance - SBOM thinking, threat modeling, security risk management - well before it became table stakes.
Re-tooled deliverables for the new statutory authority: refuse-to-accept (RTA) for cyber, SBOMs in submissions, postmarket plans. Zero cyber-related RTAs since.
Aligned templates and traceability matrices to SPDF expectations and AAMI SW96 / TIR57 inputs. Later superseded by the June 2025 final and then the Feb 3, 2026 final guidance.
The FDA published the QMSR final rule harmonizing 21 CFR Part 820 with ISO 13485. We updated quality-system inputs, including cybersecurity risk management touchpoints, in anticipation of the Feb 2, 2026 effective date.
Interim final that clarified SPDF expectations, SBOM/VEX content, and reviewer patterns after two years of Section 524B enforcement. We refreshed every template between Sept 2023 and Feb 2026 to match. Superseded by the Feb 3, 2026 final.
QMSR (21 CFR Part 820 aligned to ISO 13485) took effect Feb 2, 2026; the FDA issued its final premarket cybersecurity guidance the next day. Current binding edition. Refreshed every template, threat model, and SBOM/VEX workflow to the seven-section submission format reviewers now enforce at Technical Screening - so reviewers find each section where they expect it.
Twelve years of reps means our SPDF, threat model, SBOM/VEX, and AI-letter-response templates have been pressure-tested through hundreds of submissions - not invented yesterday in response to the latest guidance.
Anonymized to honor NDAs. Every standard, timeline, and deliverable is exactly what we shipped.
30-day FDA response window
16 weeks pre-submission (Jan - Apr 2025), first-cycle clearance in 84 days
11 months across pre-PMA and PMA review (May 2024 - Apr 2025)
Most firms won't show you what they actually ship. Here are real, redacted artifacts from real submissions - the same files we'd hand your team.
Real SBOM from a Class II SaMD submission with 312 components mapped against KEV/EPSS. Client name and component fingerprints redacted.
PDF · 14 pages
Two pages from a 47-threat STRIDE model showing the traceability matrix from threat → harm → control. Demonstrates AAMI SW96 conformance.
PDF · 2 pages
12-page response to a real FDA cybersecurity AI Request, with reviewer questions verbatim and our line-by-line response. Submission identifiers redacted.
PDF · 12 pages
Sample executive summary page from a medical device pen test report - finding rollup, severity heatmap, and remediation roadmap.
PDF · 1 page
Want a sample sent over? Email info@bluegoatcyber.com and we'll share the redacted version under a mutual NDA.
Held across the team. We don't list expired certs or letters that look impressive but aren't relevant to MedTech.
Every deliverable cross-references the relevant guidance and standards line-by-line. No hand-waving.
Competitors saying the same words can't show the same work. Here's ours, in public.
Our full pen test methodology - published, not gatekept.
Public CVD policy with intake form. Researchers can report safely.
Plain-English glossary of every FDA, AAMI, IEC, ISO standard we map to.
Six topic hubs aggregating our work, guides, and references on each subject.
Blue Goat Cyber helped us navigate our first end-to-end cybersecurity testing for our wearable medical device. Their communication was excellent, their timeline exceeded expectations, and their report helped us achieve FDA clearance without any additional questions. It was a truly seamless experience.
Blue Goat provided testing on our system for cybersecurity and provided the necessary documentation to add to our regulatory submission. They were very knowledgeable in the requirements, and performed the testing onsite which made the logistics of equipment availability easier for us. The communication was excellent, and they were able to expedite the testing and provide final reports in a very short period of time. My experience with this team was fantastic and I would not hesitate to use them again in the future.
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.
Validation we didn't write ourselves.
Medical Device Cybersecurity Solution of the Year 2026 - Blue Goat Cyber cover story
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MedTech Service Provider Excellence Award of the Year 2025 - announcement
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Christian Espinosa on FDA cybersecurity expectations and 510(k) pitfalls
ViewWhen a competitor uses the same words we do, ask them for the same receipts: named submission breakdown, 0 cyber-related RTAs, certifications with verifiable holders, redacted SBOMs and threat models you can read, and a published methodology.
30-minute strategy session. No cost, no commitment - just answers from people who've supported 275+ FDA submissions, with zero cybersecurity rejections.
