Cybersecurity for every stage of your device lifecycle.
Premarket through postmarket - one team, one accountable partner for medical device cybersecurity. Fixed-fee pricing, FDA-ready deliverables.
Premarket
33 servicesFDA Submissions
Full-Service FDA Premarket Cybersecurity
Full-service: we own 100% of SPDF, SBOMs, threat modeling, pen testing, and eSTAR documentation.
Learn moreFDA Deficiency Response
Got an FDA hold or AI letter? We close cybersecurity deficiencies fast.
Learn moreFDA-Compliant SBOM Services
Create, validate, and maintain SBOMs for premarket and postmarket.
Learn moreSecure Design & Documentation
Secure MedTech Product Design
Bake cybersecurity into your device from day one.
Learn moreMedical Device Threat Modeling
FDA-aligned threat models that identify risks early and speed approvals.
Learn moreAI/ML Medical Device Security
Defend AI/ML SaMD against adversarial attacks - and meet FDA's PCCP, GMLP, and 2025 AI-enabled device guidance.
Learn moreSaMD Cybersecurity
End-to-end FDA premarket cybersecurity package for Software as a Medical Device - cloud, mobile, and web SaMD.
Learn morePenetration Testing
Penetration Testing Services
Black, gray, and white box testing for compliance and real-world defense.
Learn moreMedical Device Penetration Testing
FDA-compliant device, firmware, app, and cloud testing.
Learn moreDevice Vulnerability & Pen Testing
10+ years testing medical devices for 510(k) and PMA clearance.
Learn moreBLE & RF Penetration Testing
Wireless interface testing for BLE, Wi-Fi, Zigbee, NFC, and proprietary RF.
Learn moreFirmware Penetration Testing
Embedded firmware extraction, reverse engineering, and exploitation.
Learn morePHI Cloud Backend Penetration Testing
Cloud backend testing for connected devices that store or transmit PHI.
Learn moreBlack Box Penetration Testing
External, unauthenticated testing of internet-facing systems.
Learn moreGray Box Penetration Testing
Authenticated testing for insider threat and application scenarios.
Learn moreWhite Box Penetration Testing
Full-knowledge testing with administrator access and source code.
Learn moreApplication Security
Application Penetration Testing
Thick client, thin client, mobile, and web app coverage.
Learn moreWeb Application Penetration Testing
Front-end, back-end, API, and mobile coverage in one engagement.
Learn moreAPI Penetration Testing
REST and GraphQL API testing with fuzzing and auth analysis.
Learn moreMobile Application Penetration Testing
iOS and Android testing covering storage, network, and platform.
Learn moreStatic Application Security Testing (SAST)
Code-level vulnerability discovery to support FDA expectations.
Learn moreDynamic Application Security Testing (DAST)
Runtime testing combined with manual penetration testing.
Learn moreNetwork & Infrastructure Testing
Network Penetration Testing
External and internal testing of your network systems.
Learn moreInternal Penetration Testing
Insider-threat simulation against your enterprise environment.
Learn moreWireless Penetration Testing
Secure your Wi-Fi and wireless attack surface.
Learn moreHIPAA Penetration Testing
Penetration testing scoped to HIPAA Security Rule expectations.
Learn moreGo-To-Market Compliance
MedTech Compliance Bundle
One program covering FDA Clearance, SOC 2, HIPAA, HITRUST, and GDPR - run in parallel for hospital-ready and EU-ready launch.
Learn moreSOC 2 Type II for MedTech
SOC 2 Type II readiness, control build, and audit support so HDO procurement stops blocking your contracts.
Learn moreHITRUST Readiness (e1 / i1 / r2)
HITRUST CSF readiness and certification support for MedTech selling into IDNs, AMCs, and large health systems.
Learn moreGDPR for Connected Medical Devices
GDPR readiness aligned to MDR/IVDR: RoPA, Article 32 controls, DPIAs, breach response, SCCs, and DPAs.
Learn moreHIPAA Compliance Program for MedTech
End-to-end HIPAA Security Rule program for MedTech, SaMD, and digital health Business Associates.
Learn moreEU Cyber Resilience Act (CRA) for Medical Devices
CRA readiness for connected medical devices: essential cybersecurity requirements, vulnerability handling, and CE-mark conformity before December 11, 2027.
Learn moreMDS2 & HSCC Procurement Disclosure Service
We complete your MDS2 (Manufacturer Disclosure Statement for Medical Device Security) and HSCC procurement responses so hospital security reviews stop blocking deals.
Learn morePostmarket
3 servicesPostmarket & Legacy
FDA Postmarket Cybersecurity
Continuous compliance, monitoring, and vulnerability response.
Learn moreLegacy Device Protection
Reduce risk on fielded devices - no redesign, no new submission, no downtime.
Learn morePostmarket SBOM Monitoring & VEX Automation
Continuous SBOM monitoring, automated VEX triage, and CAPA-ready evidence for cleared devices - so postmarket cybersecurity stops being a quarterly fire drill.
Learn moreStay ahead of CVEs. Audit-ready always.
Continuous SBOM monitoring for medical devices. Daily CVE matching, device-context triage, and VEX-ready evidence aligned to FDA Section 524B - without the noise.
- FDA Submissions
- Zero rejections
- Section 524B
- Postmarket ready
- Setup
- Fixed-fee
Common questions about our services
How engagements are scoped, sequenced, and priced - straight answers from a senior team.
Backed by MedTech leaders.
"The timeliness of this project exceeded my expectations - this was not my experience with other vendors. Blue Goat Cyber delivered a thorough, detailed report and complete testing faster than I anticipated, without compromising quality."
Not sure which service you need?
A 30-minute scoping call gets you a recommended package and a fixed-fee SOW - no hourly meters, no surprises.