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.
Quality and compliance for wearables, sleep and connected fitnessFrom wellness feature
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.
Consumer health, connected fitness and digital health companies on Qualio
ONE CLAIM CHANGES THE RULES
A wellness product becomes a medical device when one feature makes a medical claim
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.
THE QUALITY SYSTEM BEFORE THE SUBMISSION
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.
How it works
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.
DESIGN CONTROLS UNDER ISO 13485 AND IEC 62304
Your engineers stay in Jira and GitHub, and the design history keeps up
COMPLAINTS AND MEDICAL DEVICE REPORTING
A support ticket that is really a complaint reaches quality as an event
510(k) AND EU MDR SUBMISSIONS
The 510(k) compiles from work your team already approved
What device and digital health teams say
“We now have a consolidated device file which reflects the development of our product. 18 months ago, we didn't have anything like that.”
Phil Cooley
Quality Manager, Bond Digital Health
“We're so streamlined now. It's amazing where we were, compared to where we are now. I hope we get the same auditor in future, so I can say, look how wonderful this is now.”
Ami Anderson
Director of Operations & Quality Management, NeuFit
“We had Qualio in place in Q1. We got ISO 27001 in Q3. We did our SOC 2 Type 1 at the end of the year, and then Type 2 in January. It was a very quick timeline. And all of the documents we used to pass our audits came from Qualio.”
Aaron Lin
COO, Mindstep
