MEDICAL DEVICES & HEALTH

# Validation evidence a reviewer will accept.

In a regulated environment the run is not just a check. It is the record. Every step is timestamped, screenshotted and reproducible, which is what an auditor asks for.

Audit-grade evidence Deterministic replay On-premise

THE INTERFACE PROBLEM

Device displays and clinical desktop software are validated by hand because the interface is the only thing available to test against. That produces a signed checklist, not evidence — and a checklist cannot be replayed when a reviewer asks what actually happened.

**70% time saved** 
FICUS Health streamlined rehabilitation documentation with an agent that does the clicking.  
Read the case study

## The delivery lifecycle

One system, three phases, and a document at the end of each.

01 · VALIDATE

### Validation engineering and QA

Verification runs against the device display and the clinical workflow, with evidence attached.

02 · DOCUMENT

### Regulatory and quality affairs

Validation documentation produced from the run rather than written after it.

03 · OPERATE

### Clinical operations and support

Recurring workflow checks and documentation on systems already in service.

WHAT IT DRIVES

If a person can operate it, the agent can.

- Medical device displays and embedded panels
- EHR and clinical desktop clients
- Imaging and reporting viewers
- Rehabilitation and therapy software
- Laboratory instrument interfaces

WHAT THIS SECTOR REQUIRES

## Built for where it has to run.

Every action timestamped, ordered and reproducible

Evidence retained inside your own infrastructure

ISO 27001 certified, GDPR compliant, hosted in Germany

USE CASES HERE

**Audit & compliance evidence** A timestamped, reproducible record  
**Work instructions from a run** The manual writes itself as the agent walks the system  
**Legacy & virtualised apps** Citrix, terminal emulators, vendor clients  
**Manual test displacement** Make the scripts you already have executable

TARGETS IT RUNS ON

**Windows** Automate on Windows  
**Embedded HMI** Automate on Embedded HMI  
**Web** Automate on Web  
**macOS** Automate on macOS

## NEXT STEP

See it on your own medical devices & health systems.

We scope the trial with you and run it on your real environment. A person answers, within one business day.

**Scoped with you first** A short call about targets, scale and deployment.

**Terms agreed before the start** Scope and conversion terms in writing, up front.

**Nothing leaves your perimeter** On-premise and air-gapped deployment. ISO 27001, GDPR.