---
title: QMS for Medical Devices
description: A quality management system for device manufacturers — document control, CAPA, complaint handling, and change control as connected workflow boards, aligned to 21 CFR Part 820 / QMSR and ISO 13485.
---

# 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through **Draft → In Review → Approved → Released**, with a **Superseded**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.