Healthtech · Medtech & Devices · 50–200 · Europe #b032_01

Context

We build a robotic surgery system used in hospital operating rooms. Our engineering, quality and field teams are growing as more hospitals adopt the platform across several markets.

Industry

Healthtech · Medtech & Devices

Size

50–200 employees

Region

Europe

Tools budget

$1K–5K per month

Needs

Test automation & QA. Verifying our robot's embedded software still leans on manual procedures; we want more automated, traceable test runs tied to requirements.

Today: verification engineers mixing manual and scripted bench runs, traced to requirements by hand · Urgency: this year

Audit evidence collection. Each design change means chasing records across tools to keep our quality system evidence complete and inspection-ready.

Today: a quality systems owner improving an in-progress electronic quality system across sites · Urgency: this year

Support automation. Complaints and field feedback arrive through many channels, and routing them into post-market surveillance is slow and manual.

Today: a complaint specialist reviewing a database daily and reporting to a monthly board · Urgency: now

Who decides

head of compliance · security review

Expects from suppliers

Integrates with requirements management and hardware-in-the-loop rigs; Validation package suitable for a regulated device quality system; Engineers who understand embedded and robotic systems

Not a fit

Generic web-app testing tools without hardware support; Vendors unable to support computerised system validation

Stack

CI/CD pipeline in place, ticketing / issue tracker, on-prem / private cloud

Buying triggers

rapid team growth, upcoming audit or certification