Medical Device Cybersecurity Hub
Regulations, standards, and implementation guides for building secure connected medical devices. From FDA premarket submissions to post-market vulnerability management.
Section 524B is now law. Since March 2023, FDA can refuse to accept premarket submissions for "cyber devices" that lack an SBOM, post-market patch plan, and evidence of cybersecurity design. Cybersecurity is no longer optional — it's a gate for market access.
Start Here — By Role
Regulatory Affairs
FDA submission requirements, statutory mandates, and premarket cybersecurity documentation
Software / Embedded Engineer
Secure coding, threat modeling, SBOM generation, and security testing
Cloud Architect / DevOps
Backend security, encryption, HIPAA technical safeguards, and SOC 2 readiness
QMS Manager
Integrating cybersecurity into quality systems, risk management, and design controls
FDA Regulatory Authority
Statutory mandates and premarket submission guidance for cybersecurity
HIPAA & Data Privacy
HIPAA Security Rule compliance for device manufacturers handling ePHI
Implementation Guides
Step-by-step guides for implementing cybersecurity frameworks and processes
SPDF Implementation Guide
Secure Product Development Framework
SBOM Creation & Management
Formats, Tooling, and Maintenance
Threat Modeling for Medical Devices
STRIDE, PASTA, Attack Trees & DFDs
Cybersecurity Risk Assessment
Exploitability-Based Scoring & CVSS
FDA Cybersecurity Submission
Step-by-Step Premarket Checklist
SOC 2 Type II for MedTech
Trust Services Criteria & Audit Prep
Cloud Security for Medical Devices
VPC, IAM, Encryption & DR Architecture
Standards
Cybersecurity-related standards recognized by FDA for medical device development
IEC 81001-5-1
Security Activities in the Product Life Cycle
ANSI/AAMI SW96:2023
Security Risk Management (Replaces TIR57)
AAMI TIR57
Legacy Security Risk Management Principles
UL 2900 Series
Cybersecurity Testing Standard
Interactive Tools
Decision-support tools for cybersecurity classification and compliance
Content Roadmap — All Phases Complete
Phase 1: Foundation
FDA Guidance, Section 524B, IEC 81001-5-1, SPDF, SBOM, Classification Tool
Phase 2: Risk & Submission
Threat Modeling, Risk Assessment, FDA Submission How-To
Phase 3: HIPAA Compliance
Security Rule, BAAs, Device Manufacturer Guide
Phase 4: SOC 2
SOC 2 Type II for MedTech Guide
Phase 5: Cloud Security
Cloud Security Architecture Guide
Phase 6: Standards & Tools
SW96, TIR57, UL 2900, Framework Mapper