Engineering builds in one system. The evidence is assembled in another.

Requirements, tests and code sit in the tools your team chose. The proof that you built it properly sits in documents somewhere else. The two only meet when a person reconciles them. So the evidence is always behind the product, and bringing it up to date is a project before every release.

Every change costs the same to assess

Someone reads every artifact it might touch, for one line or a full rewrite.

The technical file is true for one day

By the next sprint it no longer matches the product.

Engineers won't open a second tool

So the evidence always lags behind what they built.

THE STAKES

Your technical file is a second product, and nobody is shipping it.

THE PROOF FOLLOWS THE PRODUCT

Build in your tools. The traceability builds itself.

Qualio reads the work as it happens in Jira, GitHub, Azure DevOps and your test tools, and rebuilds the links between requirements, tests, risks and design outputs automatically, even across systems. Those links are the traceability.

Change a requirement and everything it touches updates, so the trace keeps pace with the product and nobody rebuilds it by hand. Approve what it finds, and the technical documentation compiles from what you approved.

The Results

80%

Less audit prep time. A week became a day.

Sentec

510(k)

Clearance and closed an $8M Series A.

EvoEndo

Speed to market.

InVivo Bionics

DESIGN CONTROLS AND TRACEABILITY

The traceability matrix rebuilds itself on every change

User needs, design inputs and tests live where your team writes them, in Jira, Azure DevOps, TestRail or Xray. Qualio reads them, links each test to the requirement and risk it verifies, and rebuilds the traceability matrix automatically, across systems.

Change a requirement and see what it invalidates before you approve it
Know which tests still need running before a release, without asking around
Hand the auditor a trace matrix that was true this morning, not last quarter
No second tool for engineers, and no second copy of the requirements

See design controls

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

ISO 14971 RISK MANAGEMENT

Risk controls built into development

Run ISO 14971 risk management alongside your design controls. Hazards and risk controls link to the design outputs and verification that address them, so the risk file changes when the design does.

Trace every hazard to its control, and every control to the test that proves it works
Change a design output and see which risks it touches before you approve it
Evaluate residual risk and risk-benefit against the live design, not last quarter's spreadsheet
The risk management report goes into the technical documentation at its approved version

See risk management

TECHNICAL DOCUMENTATION

Technical documentation that compiles from approved work

Approved requirements, tests, risks and design outputs roll into the technical file as they are approved, so it is current the day you need it. Check the file against 510(k), CE marking under MDR and IVDR, and product registration requirements before you submit.

See what changed since your last submission, and whether it needs a new one
Assess your evidence once and see what each market still needs
Hand the notified body the complete file, laid out in the annex's own sections, straight from Qualio
Nothing enters the file without a gate decision and an approval behind it

See technical documentation