Stage 08 · Medical Device Track

Intelligence Across the Platform

Cross-cutting AI capabilities that read every artifact you've built.

Stages 00–07 each produce specific artifacts. Stage 08 capabilities cut across all of them. The FDA Reviewer Mode reads your work the way a real reviewer would — surfacing missing performance comparisons, weak substantial-equivalence arguments, traceability gaps before the deficiency letter does. The Smart Consultant Match contextually surfaces registered specialists based on what you're actively working on. These aren't sequential — they are always-on companions that engage whenever you need a fresh set of eyes.

Cards below are arranged in chronological use order. Step numbers reflect the recommended sequence; an experienced practitioner may interleave or revisit cards as needed, but a first pass through this stage should follow the order shown.

Step 1

Coming Soon

FDA Reviewer Mode

For each major artifact, an "FDA reviewer's-eye-view" critique that reads your work the way a real reviewer would. Surfaces missing performance comparisons, weak substantial-equivalence arguments, traceability gaps before the deficiency letter does. Unlocks once submission throughput produces the reviewer-pattern corpus needed for accurate critique.

Coming Soon

Step 2

Active

Smart Consultant Match

Community-driven marketplace. Consultants self-register their expertise; founders match against the live registry. Transparent six-dimension score breakdown (stage match, expertise overlap, pathway alignment, therapeutic area, jurisdictions, experience). Self-claimed vs platform-verified credentials always labeled. The platform displays consultants who registered — it does not endorse, rank by quality, or guarantee.

Launch Tool