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.