SOPs & Templates
Working documents for medical device cybersecurity, not slideware. Procedures, work instructions, and fill-in templates for risk assessment, threat modeling, SBOM, and postmarket vulnerability management. Register once with a work email and every file below unlocks.
Unlocked. Every document below is ready to download.
Medical Device Cybersecurity Program
The governing procedure the rest of the library hangs off of.
Medical Device Cybersecurity
The procedure that ties the whole program together: roles, lifecycle gates, and how security work maps to your design controls and risk management file.
🔒 Unlock to download ↓ Download WordCybersecurity Risk Assessment
Rate what a flaw would actually do to a patient, and decide what has to be fixed before release.
Cybersecurity Risk Assessment
How to run a security risk assessment on a device: scope the system, rate exploitability against patient harm, and decide what blocks release.
🔒 Unlock to download ↓ Download WordCybersecurity Risk Assessments
The worksheet that goes with the assessment procedure. Threats, scoring, and residual risk in one place a reviewer can follow.
🔒 Unlock to download ↓ Download ExcelCybersecurity Risk Management
Plan the program up front, then show what you did at the end.
Cybersecurity Risk Management Plan
A fill-in plan for how you will identify, evaluate, and control security risk across the product lifecycle.
🔒 Unlock to download ↓ Download WordCybersecurity Risk Management Report
The end-of-project record of what you found, what you fixed, and the risk you accepted, ready for a submission or an auditor.
🔒 Unlock to download ↓ Download WordThreat Modeling and Architectural Views
The part of a submission reviewers push back on most.
Threat Modeling and Architectural Views
A repeatable method for threat modeling, including the architectural views FDA expects and how to turn findings into requirements.
🔒 Unlock to download ↓ Download WordThreat Model and Architectural Views
Captures data flows, trust boundaries, and threats so the model reads the same way from one product to the next.
🔒 Unlock to download ↓ Download WordSoftware Bill of Materials
Build an SBOM that answers the lifecycle questions, not just the component list.
Software Bill of Materials
Step by step: what to include, how to handle third-party and open-source components, and where teams usually slip.
🔒 Unlock to download ↓ Download WordSoftware Bill of Materials Report
A report shell for presenting your SBOM and its analysis alongside a submission.
🔒 Unlock to download ↓ Download WordSoftware Bill of Materials End of Support and Level of Support
Track end-of-support and level-of-support dates per component, so you can answer the questions reviewers now ask.
🔒 Unlock to download ↓ Download ExcelVulnerability Management and Metrics
Prove the postmarket program is doing something.
Vulnerability Metrics Tracking
How to run postmarket vulnerability monitoring: intake, triage, and the metrics that show the program works.
🔒 Unlock to download ↓ Download WordVulnerability Metrics Tracking
A tracker for vulnerabilities and their metrics, so postmarket reporting is a lookup instead of a scramble.
🔒 Unlock to download ↓ Download ExcelThese templates are a starting point, not legal or regulatory advice. Adapt them to your quality system and your device. Provided free by MedDevice Cyber.
Questions & Answers
Are the SOPs and templates really free?
Yes. Register once with a work email and all 12 documents unlock, in editable Word and Excel formats. The same registration adds you to the daily brief, and you can unsubscribe anytime.
What does the library cover?
A governing medical device cybersecurity program SOP, cybersecurity risk assessment, risk management planning and reporting, threat modeling with the architectural views FDA expects, SBOM work instructions and report templates, and postmarket vulnerability metrics tracking.
Can we adapt the documents to our quality system?
That is the intent. They are working starting points written for device makers, meant to be edited into your QMS and your device context. They are a baseline, not legal or regulatory advice.