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Practical templates, starter systems, and documentation support for regulated teams - from SaMD and ISO 13485 to AI governance and structured compliance workflows.

ISO 27001 Free Sample Pack - Build your information security management system with editable templates. Includes ISMS scope, risk assessment, SoA, and audit checklist — ISO 27001 aligned and certification-ready.

ISO 27001 ISMS Sample Pack

ISO 13485 Medical Device QM - Build your medical device quality management system from a solid foundation. Includes QMS overview, document control, CAPA, and audit templates — ISO 13485 aligned and ready to tailor.

ISO 13485 Medical Device QMS Sample Pack

ISO 14971 Medical Device Risk Management Free Sample Pack - Tackle risk management with clear, structured templates. Includes risk management plan, hazard analysis, FMEA, and risk report — ISO 14971 aligned and ready to edit.

ISO 14971 Risk Management Sample Pack

IEC 62366-1 Usability Engineering - Jump-start usability documentation for medical devices. Includes UE plan, use specification, UI characteristics, and summative test protocol — all editable and IEC 62366-1 aligned.

IEC 62366-1 Usability Engineering Sample Pack

ISO 42001 Free Sample Pack - Navigate AI governance with confidence. Includes AI management plan, impact assessment, risk register, and transparency template — ISO 42001 aligned and ready to customize.

ISO 42001 AIMS Sample Pack

IEC 62304 Medical Device Software - Jump-start your regulatory documentation with this curated set of IEC 62304-aligned templates. Includes safety classification, requirements, traceability matrix, and test planning — ready to duplicate and tailor to your device.

IEC 62304 Medical Device Software Sample Pack

32 editable ISO/IEC 42001:2023 templates covering full AIMS - governance, risk treatment, operations, incident management & data governance. The most complete kit on the market. Built for organizations serious about AI governance, not just a policy doc.

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