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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.

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

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

The 18 mandatory documents required to establish and certify an ISO/IEC 42001:2023 AI Management System — structured, editable, and audit-ready.

ISO 42001 AIMS - 18 Mandatory Docs Kit

All 77 mandatory documents required to build an ISO 13485:2016 Quality Management System — the most complete mandatory-only medical device QMS template set available.

ISO 13485 Medical Device QMS - 77 Docs Kit

The 23 mandatory documents required to demonstrate IEC 62304 compliance across the full medical device software lifecycle — from planning through release.

IEC 62304 Medical Device Software - 23 Docs Kit

The 26 mandatory documents required to build and certify an ISO/IEC 27001:2022 ISMS — nothing you don't need, nothing missing.

ISO 27001 ISMS - 26 Mandatory Docs Kit

IEC 62366-1 usability engineering toolkit with 15 editable templates covering use specification, task analysis, use-related risk, formative and summative evaluations, and a complete validation dossier. Top-tier, audit-ready HF file for MDR/IVDR and FDA submissions.

IEC 62366-1 Usability Full Compliance Kit

Complete ISO 13485 QMS in a box: 157 editable Notion templates across 21 process areas, aligned with IEC 62304, IEC 62366-1, and ISO 14971 — build a fully audit-ready medical device QMS.

ISO 13485 Medical Device QMS Full Compliance Kit

21 editable ISO 14971:2019 templates covering the full risk management lifecycle — from hazards, FMEA/FTA, controls, and traceability through post-market review and CAPA. Top-tier, audit-ready file for NB and FDA submissions.

ISO 14971 Risk Management Full Compliance Kit

35 editable IEC 62304 templates covering the full SaMD lifecycle — from planning and architecture through V&V, risk, and post-market. Audit-ready for NB review, FDA submission, and ISO 13485 quality audits. Class A, B & C coverage.

IEC 62304 Medical Software Full Compliance Kit

The 9 mandatory documents required to implement and document a complete IEC 62366-1:2015 usability engineering process for medical devices.

IEC 62366-1 Usability Engineering - 9 Docs Kit

The 12 mandatory documents required to implement and document a complete ISO 14971:2019 risk management process for medical devices.

ISO 14971 Risk Management - 12 Mandatory Docs Kit

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.

ISO 42001 Full Compliance Kit

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

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

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.

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