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Regulated Product Lifecycle

Design controls built from
the work engineers already do

Qualio reads requirements from Jira, Azure DevOps, Linear or GitHub and tests from your test tools, links them to the risks they control and keeps the trace matrix current as the work changes.

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The traceability matrix rebuilds itself on every change

Qualio links each test to its requirement and each risk to the element it controls, across tools by the key they share. Before the review, an amber mark shows any requirement with no test, test with no result or risk with no mitigation.

Qualio traceability matrix for the Kessel Smart Pump, with user needs, design inputs, design outputs, validation, verification and risks in linked columns

Your engineers stay in their tools, and the design controls keep up

Point Qualio at the Jira or Azure DevOps project and pick the ticket types that are your requirements, and the test tool that holds your tests. Qualio reads them as they are, at the levels you name. No plugin, and nothing in the project changes. When a ticket’s status changes, the design element’s status changes with it.

Qualio traceability matrix for the Kessel Smart Pump, with user needs, design inputs, design outputs, validation, verification and risks in linked columns

Approve the design review and the documentation generates itself

Qualio gathers what is new or changed into a review for the approvers you name, who sign electronically. On approval it generates the trace matrix, risk file, specifications and test plans, and exports them with test evidence and change history.

Qualio 510(k) submission for the CardioSync App, showing requirement progress, gaps and the controls of each submission section

Platform connections

Risk management

ISO 14971 and FMEA run on the same product, each risk linked to the element it comes from or the control that mitigates it. See Risk management.

Product frameworks

The product version holds the technical file, assessed against 510(k) or EU MDR Annex II and III, with a snapshot of each version and a full download. See Product frameworks.

Your coding agents

Over the Qualio MCP server, Claude Code, Codex or any agent that speaks MCP reads the requirements, tests and risks for context, asks what a change touches, and creates or updates design elements, under the engineer’s permissions and into the audit trail.

Frequently Asked Questions

Do our engineers need to work in Qualio?

No. Requirements come from Jira, Azure DevOps, Linear or GitHub and tests from TestRail, Xray, Zephyr or Jira itself, read as they are at the levels you name. Engineers keep writing tickets where they write them now. Anything nobody keeps in a tracker, user needs or a hardware requirement, you write in Qualio itself. The approvers you name come in to sign.

Does our Jira or Azure DevOps project have to change?

No. You choose the project, the ticket types and a filter, and tell Qualio which level each one is. Qualio keeps your IDs or issues its own. There is no plugin and no required structure, and the read is one way, so nothing writes back to Jira. Whatever you leave out of the filter stays out.

Who needs a seat?

People who write or approve in Qualio pay: the product manager who signs a review, the person who owns the procedures. Everyone who reads or trains is free. An engineer who writes requirements and tests in Jira needs no seat, because Qualio reads them in and nobody edits them there.

How long does setup take, and what does it involve?

An onboarding manager works with your team about an hour a week, and customers are live in under 60 days. Someone from engineering connects the project and picks the ticket types. Qualio starts you with user needs, design inputs and design outputs, with validation and verification tests tied to each, under names you can change.

Is Design Controls validated?

Qualio runs Design Controls on its own software and publishes a feature validation pack you can use in your own validation. Reviews are approved under electronic signature and every change to a design element is in the audit trail, so the validation evidence is the same evidence the auditor reads.

Which requirement changed since the last design review?

Book a demo and we will show you the screen that connects your tracker, project, filters and fields, then a design review approved.

Part of Regulated Product Lifecycle. See everything it does.

Less time on evidence. More time on the product.