Free proven FDA submission templates. The SOPs, plan and report templates, threat model, SBOM, and metrics workbooks behind 1,000+ cybersecurity submissions, ready to drop into your quality system. Browse every document below, then download the raw DOCX or XLSX.
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The SOPs define the process: the lifecycle, the risk assessment methodology, and threat modeling. The templates are fill in documents, pre-structured so the plan you file matches the SOP you follow. The work instructions are step by step procedures covering who runs a task, with what, and what gets stored where.
The master SOP runs the full lifecycle. It moves phase by phase from planning and the cybersecurity risk management plan, through design input threat modeling and design output SBOM and secure code analysis, into cybersecurity testing and risk assessment, then production and post-production obligations.
The Cybersecurity Risk Management Report is the submission report template, and the Cybersecurity Risk Management Plan is the plan you file. The SBOM Report wraps the machine readable SBOM with the purpose, scope and attachment structure around it. The SOPs sit behind them as the process those documents were produced under.
They are meant to be edited. Every document downloads as raw DOCX or XLSX with nothing to install, and the library says plainly to edit the language to fit your quality system. What carries over is the structure: the sections, the acceptance criteria, and the traceability between documents.
They cross reference. The risk assessments workbook is the working spreadsheet behind the risk management report, the SBOM end of support sheet attaches directly to the SBOM Report, and the vulnerability metrics workbook pairs with the metrics work instruction. Used together they produce one traceable set rather than five loose files.