Free self-assessment

SaMD: Building It Right the First Time

A readiness self-assessment for funded HealthTech and MedTech startups developing software as a medical device (SaMD), regulated digital health, AI-enabled medical technology, or software-enabled medical devices.

Instant readiness profile • Regulatory + Clinical + Technical + Commercial alignment

What it reveals

Strong software alone doesn't make a product commercialization-ready

This assessment looks for alignment across intended use, claims, architecture, risk, evidence, regulatory pathway, clinical strategy, and funding assumptions. Those are the places where gaps turn into rework.

Select Yes, Partly, or No for each statement (or N/A where offered). In Areas 1 through 5, Yes indicates readiness, Partly indicates work remains, and No indicates a gap.

Area 6 asks about risks instead, so it is reverse-scored: Yes indicates a risk, Partly a potential or partial risk, and No means that risk is not present.

Items marked Priority carry more weight. Any negative response on a priority statement produces a Red area, and two or more Partly responses on priority statements produce at least Yellow.

You'll get a Green, Yellow, or Red profile for each area, plus the priority gaps to tackle next. There's no artificial single "regulatory score."

You'll move through 6 areas
    38 statements, one area at a time. Your profile appears instantly at the end.