← PRODUCT
TEMPLATES
Quality artefacts you can install.
Browse Premium and Community templates for your QMS. ISO 13485 SOPs, IEC 62304 requirements schema, SBOM scaffolding, risk register — installed as proper databases in your /qms directory, ready to edit and version-control.
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Premium templates, audited
Written and maintained by our regulatory team. Pre-mapped to FDA PCCP guidance, IEC 62304, and ISO 13485. Start from something that's already been tested in a submission.
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Community templates, battle-tested
From teams that have already filed. Peer-reviewed and tagged by the regulation they address. Free.
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Install, not import
Templates land as databases in your /qms directory — same format as everything else. They version-control, they diff, they feed into your DHF. Not a separate thing to maintain.