---
title: "Risk Management Software for Life Sciences | Qualio"
canonical: "https://www.qualio.com/compliance-platform/risk-management"
updatedDate: "2026-11-03T10:26:21.000Z"
description: "Trace every hazard to its control and the test that verifies it, rebuilt as the design changes. One risk register across quality and product. The risk management report in the technical documentation at its approved version. ISO 14971, ICH Q9 and IEC 62304."
---

# Risk Management Software for Life Sciences | Qualio

Trace every hazard to its control and the test that verifies it, rebuilt as the design changes. One risk register across quality and product. The risk management report in the technical documentation at its approved version. ISO 14971, ICH Q9 and IEC 62304.

## Trace every hazard to its control and test

Qualio rebuilds the links as the design changes, and the risk management report goes into the technical documentation at the version your approvers signed.

## Risk controls built into development

Each hazard carries its hazardous situation, the harm, and the risk before and after mitigation. Its controls link to the design outputs that implement them and the tests that verify them. Read any hazard through to the test behind it.

## The risk file changes when the design does

Requirements and design outputs stay in [Jira](/integrations/jira) or [Azure DevOps](/integrations/azure-devops). Qualio reads them as they are. Change one and the links to each hazard rebuild, so the risks a change touches show before anyone approves it.

## The risk management report goes into the technical documentation at its approved version

The report is a controlled document, reviewed and approved in Qualio. The product version’s technical documentation takes it at that version, so the reviewer reads the report your approvers signed and version 2.0 starts from it. See [Product frameworks](/compliance-platform/product-frameworks).

## Platform connections

### Design controls

The links that trace a requirement to its test also trace a hazard to its control: one trace matrix from requirement to hazard to test, rebuilt on every change. See [Design controls](/compliance-platform/design-controls).

### Quality Management

The hazard in the device file and the risk behind a change control are the same entry in the same register. A risk is reviewed once, whichever side raised it.

### Compliance Frameworks

ISO 14971 and ICH Q9 are mapped clause by clause to your risk procedure beside ISO 13485 and cGMP. When a risk, control or test changes, Qualio reassesses and recommends a fix for any gap.

## Frequently Asked Questions

### What is a risk management file?

The risk management file is the set of records ISO 14971 asks a device manufacturer to keep: the plan, the hazards and hazardous situations, the estimate and evaluation of each risk, the controls and their verification, the overall residual risk evaluation and the risk management report. A notified body or FDA investigator reads it as evidence the process was followed.

### Does Qualio support ICH Q9 as well as ISO 14971?

Yes. Quality, product, security and privacy risks are one register, assessed on the same criteria. A risk assessment opens from the deviation, change control or CAPA that needs it, is signed electronically and stays linked to that event. ICH Q9 sits in the same library as ISO 14971, mapped to your risk procedure beside cGMP.

### Can we bring our existing risk file into Qualio?

Yes. The hazards, controls and assessments become the risk file for each product in Qualio. The requirements and tests they link to are read from Jira, Azure DevOps, [TestRail](/integrations/test-tools), Xray or Zephyr as they are. Bringing an existing hazard analysis across is part of onboarding.

### How does the risk file stay current when the design changes?

Each hazard links to its control, the design output that implements it and the test that verifies it. When a requirement or design output changes in the tracker, Qualio rebuilds the links. The hazards the change touches show before it is approved, and residual risk is evaluated against the design as it stands.

### Do engineers need a licence to see the hazards their work controls?

No. Reading is free for everyone, so an engineer can open the hazard their requirement answers without a seat. Engineers sign in Qualio only as approvers, and approvers are licensed. The quality and regulatory people who write the risk file are licensed too.

## Is the risk file current this morning?

Bring your hazard analysis and your last design change. We will trace the change to the hazards it touched and show the report inside the technical documentation.

Part of Regulated Product Lifecycle. [See everything it does.](/compliance-platform/product-lifecycle)