Healthtech · Clinical Software · 50–200 · Asia-Pacific #b041_21

Context

We build doctor-prescribed therapy apps that are regulated as medical devices and covered by public insurance in our home market.

Industry

Healthtech · Clinical Software

Size

50–200 employees

Region

Asia-Pacific

Tools budget

$1K–5K per month

Needs

Audit evidence collection. Medical device rules need design and test records for every release, and assembling them slows our product teams.

Today: a medical-team quality management function documents device software development for regulators · Urgency: this year

Test automation & QA. Each app update needs documented verification, and too much of our testing is still manual.

Today: engineers standardise on a typed web language and lean on generative AI helpers · Urgency: this year

Who decides

vp engineering · security review

Expects from suppliers

Familiarity with medical device software rules; Support in our local language; Exportable records for regulators

Not a fit

Tools with no audit trail; Vendors unwilling to support regulated validation

Stack

CI/CD pipeline in place, LLM APIs in production, compliance tooling in place

Buying triggers

regulatory change, new market or product launch