Blue Goat Cyber
Medical device cybersecurity firm providing penetration testing services for FDA submissions.
medical device cybersecurity: ISO 14971 • FDA Guidance • UL 2900 • AAMI TIR57 • NIST 800-115 • IEC 62304 • ISO 13485 • AAMI TIR97 • ISO 27001 • IEC 81001-5-1 • IEC 62443-4-1
You’re building breakthrough medical technology to improve lives. But with FDA requirements, evolving cyber threats, and tight timelines, cybersecurity can feel overwhelming — and high stakes.
We specialize in full-service cybersecurity for medical devices — so you can protect your patients, meet regulatory demands, and bring your device to market with confidence.
Buyer Snapshot
Best for
- Medical device manufacturers seeking FDA compliance.
- Healthcare providers needing to secure patient data.
- SaaS companies requiring SOC 2 compliance.
How engagement typically works
- Initial 30-minute discovery session.
- Tailored proposal development.
- Collaborative review process.
Typical deliverables
- FDA-Compliant Penetration Test Reports
- Secure MedTech Product Design Consulting
- FDA-Compliant SBOMs
- HIPAA Security Risk Analysis
- SOC 2 Penetration Test Reports
Good to know
- Best when clients are prepared to engage in a structured discovery and proposal process.
Pricing
Model:
Per project
HQ:
US
Languages:
English
Claim status:
Listed
Services & Capabilities
Medical Device Cybersecurity
Provider Type:
Service Firm
Service Categories:
Penetration Testing (Manual/Hardware), Threat Modeling & Risk Analysis, RTA Rescue (Submission Fix), Vulnerability Management (Post-Market)
Pen Testing Available:
Yes
Submission Stage Support:
Ready for 510(k)/MDR Submission, RTA Fix (FDA Refusal Response)
Device Types Supported:
Software as a Medical Device (SaMD), Connected Hardware (IoT/WiFi/Bluetooth)
Sbom Formats Supported:
SPDX, Other
Standards Frameworks:
ISO 14971, FDA Guidance, UL 2900, AAMI TIR57, NIST 800-115, IEC 62304, ISO 13485, AAMI TIR97, ISO 27001, IEC 81001-5-1, IEC 62443-4-1
Threat Modeling Available:
Yes
Sbom Management Available:
Yes
Vulnerability Monitoring Available:
Yes
Rta Rescue Available:
Yes
Additional medical_device_cybersecurity Details
Provider Type
Service Firm
Service Categories
Penetration Testing, SBOM Management, Threat Modeling, Vulnerability Management
Submission Stage Support
Pre‑Submission, Ready for 510(k)/MDR, RTA Fix
Device Types Supported
SaMD, Connected hardware, Medical devices
Standards Frameworks
ISO 14971, FDA Guidance, UL 2900, AAMI TIR57, NIST 800-115, IEC 62304, ISO 13485, AAMI TIR97, ISO 27001, IEC 81001-5-1, IEC 62443-4-1, HIPAA
