SPDF
Secure Product Development Framework
End-to-end secure development lifecycle the FDA expects to see referenced and evidenced in every cyber device submission.
FDA-Aligned Secure Product Development Framework
Build an SPDF the FDA Actually Accepts.
We design, document, and implement your Secure Product Development Framework for 510(k), De Novo, and PMA submissions - aligned with FDA Section 524B, AAMI SW96, IEC 81001-5-1, and ISO 14971.
250+ Submissions · Zero Cybersecurity Rejections · 100% Success Rate
- Clearance Commitment
- Fixed-Fee Pricing
- Unlimited Retests
- FDA eSTAR Aligned
- Free 30-min call
- No obligation
- Senior expert
- Fixed fee in 24h
- NDA on request
- US-based team
Trusted by leading MedTech companies since 2014
What's included
Reviewer-ready deliverables in one engagement
Every secure medtech product design engagement ships with the artifacts FDA reviewers expect to see - traceable, complete, and aligned with current guidance.
- Security architecture and trust boundaries
- Cryptography and key management
- Secure boot and update strategy
- Developer training for medical teams
Relevant standards
Standards this service maps to
Every secure medtech product design engagement produces evidence aligned to the regulatory and consensus standards FDA reviewers and notified bodies expect to see - traceable, complete, and ready to drop into your ISO 13485 quality system.
Featured site-wide
FDA 2026 Guidance Featured
FDA Premarket Cybersecurity Guidance (Feb 3, 2026)
Defines the SPDF, Section 524B submission package, threat modeling, SBOM, security architecture views, and cybersecurity testing every cyber device submission must include.
IEC 81001-5-1
Health Software Security Activities
International standard for security activities across the health software product lifecycle.
IEC 62443-4-1
Secure Product Development Lifecycle
Industrial-strength secure-development-lifecycle requirements applied to connected medical devices.
ISO 13485 Featured
Medical Device Quality Management System
International QMS standard for medical devices. Cybersecurity deliverables are designed to slot into your existing 13485 QMS without parallel paperwork.
ISO 14971 Featured
Medical Device Risk Management
Foundational risk management standard. Cybersecurity risk is tied directly to patient-safety risk in the 14971 file.
Related services mapped to the same standards
Full-Service FDA Premarket Cybersecurity
Full-service: we own 100% of SPDF, SBOMs, threat modeling, pen testing, and eSTAR documentation.
Learn moreFDA-Compliant SBOM Services
Create, validate, and maintain SBOMs for premarket and postmarket.
Learn moreMedical Device Threat Modeling
FDA-aligned threat models that identify risks early and speed approvals.
Learn more FAQ
Secure MedTech Product Design FAQs
In their words
Backed by MedTech leaders.
HT
"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."
Hank Tucker
CEO · MedTech Manufacturer
Ready to start Secure MedTech Product Design?
Secure MedTech Product Design - scoped, fixed-fee, FDA-ready.
We design, document, and implement your Secure Product Development Framework for 510(k), De Novo, and PMA submissions - aligned with FDA Section 524B, AAMI SW96, IEC 81001-5-1, and ISO 14971.