A Git-native QMS built around the way AI SaMD teams actually work — version-controlled, auditable, and yours to keep.
Compile a submission-ready DHF from your release tag. 300 pages in seconds.
MFA-backed, 21 CFR Part 11 compliant signatures on every controlled document merge.
Requirements-to-tests coverage tracked automatically. Gaps fail CI before they ship.
Software Bill of Materials rebuilt from your dependency manifests on every commit.
ISO 13485 SOPs, IEC 62304 templates, risk registers — install in one click.
Notion-like editing with slash commands, @mentions, nested pages, and an audit trail that backs a 510(k).
Your QMS lives as plain markdown in your own repo. Leave anytime — everything stays yours.
Install the GitHub App, connect your QMS repo, and get status checks on every PR.
Edit a document and a PR opens automatically. Reviewers comment. eSignatures gate the merge.