Healthtech · Medtech & Devices · 50–200 · North America #b031_15

Context

We make an implanted sensor system for people managing a chronic metabolic condition, with a lean team handling quality and post market obligations.

Industry

Healthtech · Medtech & Devices

Size

50–200 employees

Region

North America

Tools budget

$1K–5K per month

Needs

Regulatory reporting. Post market complaint intake and adverse event reporting rely on spreadsheets and manual trending.

Today: a small regulatory team preparing submissions and post-market reports in documents and spreadsheets · Urgency: this year

Document AI & extraction. Quality engineers read long free text complaint narratives by hand to classify and route them.

Today: manual drafting and review of regulatory and clinical documents by specialists · Urgency: later

Who decides

head of compliance · team trial

Expects from suppliers

Complaint handling workflow with regulatory report generation; Validated configuration for quality use; Fair pricing for a small public company

Not a fit

Generic customer service ticketing tools; Large suites requiring consultants to deploy

Stack

ticketing / issue tracker, compliance tooling in place

Buying triggers

regulatory change, cost pressure