Healthtech · Medtech & Devices · 50–200 · Europe #b032_05

Context

We develop an implantable heart support pump moving from clinical studies toward commercial launch. Our teams cover hardware, embedded control software, manufacturing and quality.

Industry

Healthtech · Medtech & Devices

Size

50–200 employees

Region

Europe

Tools budget

$1K–5K per month

Needs

Continuous compliance monitoring. We recently certified our quality system and now need to keep it continuously compliant as processes and teams change quickly.

Today: a freshly certified quality system kept current by the quality team through periodic reviews · Urgency: now

Test automation & QA. Our control software and clinician-facing tools need repeatable automated verification before every pivotal study build.

Today: software engineers verifying pump control code by hand ahead of a pivotal trial · Urgency: this year

Audit evidence collection. Process validation records and supplier files are gathered by hand before each inspection, which strains a small quality team.

Today: records across design, manufacturing and servicing compiled by hand for certification · Urgency: now

Who decides

head of compliance · security review

Expects from suppliers

Proven use at implantable device manufacturers; French and English support; Validation documentation included

Not a fit

Tools built only for pure software companies; Pricing tied to large enterprise seat counts

Stack

on-prem / private cloud, ticketing / issue tracker

Buying triggers

upcoming audit or certification, new market or product launch