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Medical Device Cybersecurity Guide
From the CyberMed book: practical guidance on designing secure devices, testing them, managing post-market security, and preparing the cybersecurity documentation FDA expects in eSTAR submissions. No signup required.
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Chapter 3
Security by Design
- Section 3.5Security Architecture Views: Showing Your DesignArchitecture views are like blueprints that show how security is built into your device. They help: - FDA reviewers understand your security design - Development teams implement consistently - Securit…
- Section 3.6Threat Modeling: Thinking Like an AttackerThreat modeling is a structured process to: - Identify what could go wrong - Understand how attacks might happen - Prioritize based on risk - Design appropriate defenses
- Section 3.7Security Risk AssessmentWhile threat modeling identifies what could go wrong, risk assessment determines: - How likely is it to happen? - What's the impact if it does? - Is the risk acceptable? - What controls are needed?
- Section 3.8Security Control ImplementationDon't rely on single security controls. Layer defenses:
Chapter 4
Secure Development & Testing
Chapter 5
Post-Market Security Management
- Section 5.3Building Your Vulnerability Monitoring ProgramYou can't fix what you don't know about. Effective monitoring requires multiple information sources:
- Section 5.6Coordinated Vulnerability DisclosureCoordinated Vulnerability Disclosure (CVD) is the process of working with security researchers who find vulnerabilities. FDA references ISO 29147:2018 and ISO 30111:2013 as standards for CVD.
- Section 5.10Security Metrics and Continuous ImprovementTrack metrics that matter:
Chapter 6
eSTAR Submission Documentation
- Section 6.3Security Architecture Views for eSTAR SubmissionYour security architecture views shouldn't be created twice - once for development and again for FDA. Instead, plan from the beginning to create views that will serve both purposes, then enhance them …
- Section 6.4Threat Model Documentation for eSTAR SubmissionYour threat modeling effort (detailed in Chapter 3.6) serves as the foundation for understanding your device's attack surface. As you prepare for submission, your existing threat model needs enhanceme…
- Section 6.5Cybersecurity Risk Assessment Documentation for eSTAR SubmissionYour cybersecurity risk assessment (developed through the process in Chapter 3.7) forms the backbone of your security argument to FDA. However, the risk analysis you use internally needs enhancement t…
- Section 6.6Security Controls Documentation for eSTAR SubmissionYour security controls represent the tangible measures protecting patients from cybersecurity threats. While Chapter 4 covered implementing these controls during development, this section focuses on d…
- Section 6.7Safety and Security Risk Integration Documentation for eSTAR SubmissionThe integration of safety and security risk management (developed through Chapter 3.7 processes) represents one of FDA's most critical review areas. This section focuses on documenting your integrated…
- Section 6.8SBOM Analysis and Documentation for eSTAR SubmissionYour Software Bill of Materials (SBOM) and component analysis (developed through Chapter 4.4 processes) serves multiple purposes: supply chain risk management, vulnerability tracking, and regulatory c…
- Section 6.9Security Testing Documentation for eSTAR SubmissionYour security testing activities (conducted per Chapter 4.5) generate the evidence FDA needs to verify that your security controls work as intended. This section focuses on transforming your testing w…
- Section 6.10Cybersecurity Management Plan Documentation for eSTAR SubmissionYour cybersecurity management plan (developed through Chapter 5 processes) serves as your commitment to FDA and customers for ongoing device security throughout its operational lifetime. For "cyber de…
- Section 6.11Cybersecurity Labeling Documentation for eSTAR SubmissionYour cybersecurity labeling serves as the critical bridge between your device's security implementation and users' ability to deploy and maintain it securely. This section focuses on transforming your…
- Section 6.12Common eSTAR Submission Pitfalls and How to Avoid ThemEven well-documented cybersecurity programs can encounter submission challenges if the documentation doesn't align with FDA's review expectations. This section focuses on transforming your comprehensi…
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