FDA, SOC 2, HIPAA, HITRUST. One program. Parallel tracks.
FDA clearance gets you on the market. Hospitals decide whether you stay there. We run FDA cybersecurity, SOC 2 Type II, HIPAA, and HITRUST in parallel - reusing one control set across all four - so your commercial launch isn't blocked by procurement six months after approval.
Hospital-ready at launch. Not 12 months later.
- FDA 524B aligned
- SOC 2 Type II
- HIPAA Security Rule
- HITRUST e1 / i1 / r2
- Free 45-min GTM compliance call
- Single fixed-fee for all four tracks
- Crosswalk delivered in week 1
- One evidence vault, four attestations
Trusted by leading MedTech companies since 2014
Why MedTech innovators stall after FDA clearance
The FDA is the start line, not the finish line. HDOs ask harder questions.
Procurement freezes the deal
Hospital security teams send a 300-line questionnaire. Without SOC 2 + HIPAA evidence on hand, the deal slips a quarter - or two.
Duplicated work, duplicated cost
Most teams do FDA, then SOC 2, then HIPAA, then HITRUST sequentially. Each one re-collects the same evidence. We run them in parallel from one control set.
Frameworks don't speak to each other
FDA reviewers want patient-safety threat models. Auditors want trust-services criteria. We translate once and map everywhere - so nothing gets re-written.
One control set. Four attestations.
The FDA, SOC 2, HIPAA, and HITRUST overlap on roughly 70% of the controls a MedTech innovator needs for hospital procurement. We build the evidence once and map it into every framework in parallel - cutting cost, calendar time, and the duplicate-questionnaire grind.
| Control area | FDA | SOC 2 | HIPAA | HITRUST |
|---|---|---|---|---|
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Risk assessment & threat modeling
ISO 14971 + ANSI/AAMI SW96 patient-safety threat model, reused as the SOC 2/HIPAA/HITRUST risk assessment.
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Policies & procedures (SDLC, change, IR)
One policy set: SDLC, change management, incident response, vendor management. Mapped to each framework's policy requirements.
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Access control & identity
Least privilege, MFA, role-based access, joiner/mover/leaver - one control, four attestations.
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Encryption (at rest & in transit)
TLS 1.2+, KMS-backed key management, documented for FDA crypto rationale and SOC 2/HIPAA/HITRUST controls.
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SBOM + vulnerability management
FDA-aligned SBOM (SPDX/CycloneDX) + continuous CVE monitoring becomes the SOC 2 vuln-mgmt and HITRUST patching evidence.
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Penetration testing
One white-box test campaign satisfies FDA premarket testing, SOC 2 CC4.1, HIPAA evaluation, and HITRUST 10.b.
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Logging, monitoring & alerting
Centralized logs with 1-year retention, alerts for security events. Reused across SOC 2 CC7, HIPAA audit controls, HITRUST 09.aa.
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Incident response & breach notification
One IR runbook covering FDA postmarket reporting, SOC 2 incident process, HIPAA breach notification, and HITRUST 11.
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Vendor / Business Associate management
BAAs, vendor risk reviews, and SBOM upstream evidence - one register, four frameworks.
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Workforce training & awareness
Annual security + HIPAA training tracked in one LMS, evidence reused across SOC 2, HIPAA, HITRUST.
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Postmarket vulnerability disclosure
Coordinated VDP and CVE handling required by FDA 524B - reused as the SOC 2/HITRUST vuln-disclosure control.
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Audit-ready evidence repository
One evidence vault: FDA eSTAR attachments, SOC 2 fieldwork pulls, OCR/HHS audit, HITRUST MyCSF uploads.
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Reviewer-ready deliverables in one engagement
Every gtm compliance bundle (fda + soc 2 + hipaa + hitrust) engagement ships with the artifacts FDA reviewers expect to see - traceable, complete, and aligned with current guidance.
- FDA 510(k) / De Novo / PMA cybersecurity submission
- SOC 2 Type II readiness and audit support
- HIPAA Security Rule risk analysis and BA agreements
- HITRUST CSF e1 / i1 / r2 readiness for HDO procurement
- Single crosswalk - one set of controls, four attestations
How the bundled program runs
Parallel tracks, one project manager, one evidence vault.
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01
1. Crosswalk & gap assessment
Week 1-2: we map your current state to all four frameworks and produce a single remediation backlog with shared controls flagged.
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02
2. Control build (parallel)
Week 3-12: SDLC, access, encryption, logging, IR, vendor mgmt, training. Built once, mapped to FDA + SOC 2 + HIPAA + HITRUST.
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03
3. Evidence + testing
Threat modeling, SBOM, pen testing, and 3-6 months of operating evidence collected once, reused across all four.
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04
4. Attestations & submission
FDA cybersecurity submission, SOC 2 Type II audit support, HIPAA risk analysis sign-off, HITRUST validated assessment - sequenced to your GTM date.
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Backed by MedTech leaders.
"Blue Goat Cyber's depth of expertise was impressive. We had no in-house cybersecurity experience, and their team guided us through every step of the FDA process. The penetration testing and SBOM testing were thorough and gave us complete confidence."
GTM Compliance Bundle (FDA + SOC 2 + HIPAA + HITRUST) - scoped, fixed-fee, FDA-ready.
FDA clearance gets you on the market. Hospitals decide whether you stay there. We run FDA cybersecurity, SOC 2 Type II, HIPAA, and HITRUST in parallel - reusing one control set across all four - so your commercial launch isn't blocked by procurement six months after approval.