IEC 62304 lifecycle, done right from day one
IEC 62304 software lifecycle with ISO 14971 hazard analysis, FDA 510(k)/De Novo/PMA deliverables, and Design History File management.
The lifecycle your FDA reviewer expects
Every new device project is auto-seeded with the 9-phase IEC 62304 software lifecycle plus ISO 14971 hazard management and 21 CFR 820.30 design controls. 40 readiness criteria cover Class A/B/C segregation, SOUP, usability engineering, and post-market surveillance.
Everything devices in your industry actually need
Design Reviews Out-of-the-box
42 readiness criteria auto-seeded on every new device. No blank-page starts.
Native MBSE Stencils
SysML palette with 11 blocks specific to your domain — drop and go.
Device-type Templates
12 archetypes pre-configured so you start from the right place.
AI-assisted, Domain-aware
Our AI advisor knows IEC 62304 + ISO 14971 — not generic SE. Prompts, references, and deliverables frame themselves correctly.
Device archetypes we support
Your first industry pack is free.
Every subscription includes one vertical pack at no extra cost. Add Medical Device today — $0 for your first pack, forever.