QMS for Medical Devices

The QMS app gives a medical-device manufacturer the four workflows a quality system runs on, as connected boards backed by an auditable state machine. It installs with a realistic demo dataset so you can see the whole system working on day one, and it pairs with the medical-device framework pack in Compliance Yoke for readiness and crosswalk reporting.

What's inside

The app installs four lifecycle boards, each a Kanban view of records moving through defined states. Every state change is recorded on an append-only event log, so you always have a history of who moved what and when.

Document Control

Controlled documents — SOPs, work instructions, forms, and records — move through Draft → In Review → Approved → Released, with a Superseded terminal state for retired revisions. Approval and release are explicit steps, so a released document is always one that went through review.

CAPA

Corrective and preventive actions run Open → Investigation → Action Plan → Verification → Closed. Verification is its own state before closure, so an action is only closed after its effectiveness has been checked. CAPAs can be sourced from complaints, audits, or internal findings.

Complaint Handling

Device complaints run Received → Under Investigation → Resolved → Closed, with a field to flag whether a complaint is reportable to the regulator. The flow keeps intake, investigation, and closure distinct so nothing skips a step.

Change Control

Engineering and process changes run Requested → Review → Approved → Implemented → Verified. Approval gates implementation, and verification confirms the change did what it was meant to before the record reaches its terminal state.

How it fits together

The four boards are designed to reference each other the way a real quality system does: a reportable complaint opens a CAPA, the CAPA's root-cause fix becomes a change, and the change updates a controlled document. The demo data ships this chain already wired so the relationships are visible immediately.

Getting started

Install the app from the Marketplace. On install it seeds a demo dataset across all four boards — every lane starts with at least one record — so you can explore the workflows before adding your own. Removing the app takes the demo data with it and retires the workflow definitions without deleting your history.

The QMS app is available on the Enterprise plan.