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

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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

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

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

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

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