---
title: "QMS for Wearables and Consumer Health Devices | Qualio"
canonical: "https://www.qualio.com/solutions/consumer-health"
updatedDate: "2026-11-04T14:49:24.000Z"
description: "When a wearable, sleep or fitness feature becomes a medical device, Qualio sets up the ISO 13485 and QMSR quality system around the tools your engineers use."
---

# QMS for Wearables and Consumer Health Devices | Qualio

When a wearable, sleep or fitness feature becomes a medical device, Qualio sets up the ISO 13485 and QMSR quality system around the tools your engineers use.

## From wellness feature to cleared device

Design controls from Jira and GitHub, complaints from your support desk, and a quality system built to ISO 13485 and the QMSR. Ready before the first submission.

## A wellness product becomes a medical device when one feature makes a medical claim

FDA's general wellness guidance, revised in January 2026, leaves room for sleep, fitness and stress features. A feature that detects or diagnoses a condition does not qualify. Once one crosses that line, the company needs a quality system under the QMSR, design controls and complaint handling, usually before it has a quality team.

### The evidence lives in Jira and GitHub

The design history gets rebuilt by hand for the submission.

### Complaints arrive at consumer scale

Device complaints sit in the support queue with everything else.

### Nobody owns quality yet

The engineers own it, on top of shipping the product.

## Qualio sets up the quality system around the tools your teams already use

Qualio reads requirements and tests from Jira, GitHub, Linear and Azure DevOps and builds the design controls and trace matrix from them. It brings support tickets in from Zendesk and Intercom as complaints, and assesses the whole quality system against ISO 13485, the QMSR, IEC 62304 and ISO 14971 as it changes. Connected-fitness companies such as Tonal chose Qualio to do it.

To a 510(k)-ready QMS

Cleared on a Qualio quality system

To ISO 13485 certification

## Your engineers stay in their tools. Quality works in Qualio.

Nobody on the engineering team needs a seat to keep the design controls current.

### Design Controls

Qualio reads requirements and tests from your engineering tools and rebuilds the trace matrix on every change, with each risk linked to the control that addresses it.

### Quality Management

Procedures, training, complaints, CAPAs and suppliers, set up to ISO 13485 and the QMSR from Qualio's templates.

### Compliance Frameworks

Qualio assesses every record against ISO 13485, the QMSR, IEC 62304 and ISO 14971 as it changes, and against EU MDR when you add a market.

## Your engineers stay in Jira and GitHub, and the design history keeps up

- Choose the issues that are requirements and tests, and Qualio reads them every hour
- See what a change touches before anyone approves it
- Approve the design review, and the trace matrix, risk file and specifications generate from it

## A support ticket that is really a complaint reaches quality as an event

- Bring matching Zendesk or Intercom tickets in as complaints, with the ticket linked
- Record the reportability decision with the complaint, dated and signed
- Open the CAPA from the complaint, and trend complaints by product and failure

## The 510(k) compiles from work your team already approved

- Build the submission from approved documents, with each section's gaps shown before you file
- Keep each cleared version on file while the product keeps shipping
- Reuse the same documents when you add the EU or another market

## What device and digital health teams say

## More for consumer health teams

## Less time on paperwork. More time on the product.