An inscription containing the details of construction, and who made it.
A QMS for small medical device teams — effortless day to day, audit-ready by construction. Operational on day one, priced for a small team.
Someone stands behind it.
Write like a wiki. Every page, a controlled record.
A complete quality workspace — feature by feature.
Everything a small device team needs to write, control, and prove its quality system — approachable on the surface, unimpeachable underneath.
Edit like it's a wiki
Anyone on the team can open a page and improve it directly — no request queues, no gatekeepers. The system gets better because the people using it are empowered to make it better.
An immutable version history
Every save becomes a new edition automatically — preserved, never overwritten. The full lineage of a document is always there, captured quietly in the background with no manual checkpoints to remember.
Sign and approve, Part 11 compliant
Route a document for approval and collect 21 CFR Part 11–compliant electronic signatures — each bound to the exact content it approved and the person who stands behind it.
An audit log that stays out of the way
Every change and approval is recorded in an append-only trail — comprehensive enough to satisfy an auditor, quiet enough that your team never notices it working.
Attachments as first-class artifacts
PDFs, images, test data, and exported reports live alongside the document as versioned, controlled artifacts — not loose files scattered across a shared drive.
See what needs attention, when
A dashboard that surfaces what's pending, overdue, or due for periodic review — approvals waiting on you, documents to revisit, gaps to close — so nothing slips through the cracks.
Coming soon
What we're building next — extending the same compliant-by-construction foundation, not bolting features onto the side.
Training management
Assign, track, and record training against procedures — competency tied directly to the documents that change.
Out-of-the-box validation
Pre-built validation packages so you can stand up a compliant system without writing the protocols yourself.
Templates
Starter procedures, forms, and records mapped to ISO 13485 and the QMSR — edit to fit instead of starting from a blank page.
Regulated-system behavior, built into the foundation.
Every controlled document carries its own verifiable provenance — author, approver, edition, date, and content hash — so when an auditor walks in, the record speaks for itself.
Request a pilot.
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