Healthtech · Medtech & Devices · 11–50 · North America #b031_23

Context

We are an early stage neural interface startup building our first regulated product and our quality processes at the same time.

Industry

Healthtech · Medtech & Devices

Size

11–50 employees

Region

North America

Tools budget

under $1K per month

Needs

SOC 2 / ISO 27001 automation. We are standing up our quality system from scratch and need templates and controls without large consulting fees.

Today: a small team handling security attestations only when a customer or partner asks · Urgency: later

Application security & code scanning. Cybersecurity documentation for our design history file is written by hand, without tooling for threat analysis.

Today: a quality engineer documenting software cybersecurity within design history files · Urgency: this year

Who decides

cto · founder led

Expects from suppliers

Starter quality system templates aligned to device standards; Cybersecurity documentation help for submissions; Pricing workable for a seed stage team

Not a fit

Enterprise suites with long rollouts; Consultancies billing large retainers

Stack

ticketing / issue tracker, cloud: GCP-class hyperscaler

Buying triggers

upcoming audit or certification, new market or product launch