Francophone510(k) ConsultantBack to the analysis

What changed

What you will notice, newest first.

2026-08-23The record behind every answer

  • Every figure now says what it was measured on, in which era, on which path, and judged by whom — and the exact-match figure sits beside the headline.
  • The predicate card shows what the predicate cites, which of those was recalled, the recall’s reason, and whether it touches the compared feature.
  • A precedent table — the cleared devices in your product code, most cited first — and alternatives by feature.
  • Each standard shows its FDA-recognized edition beside the edition on record.
  • Corrections are marked as yours, can be undone, and are offered back on later dossiers. Nothing learned crosses sponsors.
  • Run history with what changed between runs; the recall re-check stated on open.
  • The worked example is open on arrival. Documents: classification rationale, testing roadmap, pre-sub package, RTA checklist with locations, a colleague brief.
  • Our error rates, the system card, terms, and this help page.

2026-08-22The words

  • Every sentence rewritten to be understood on first read — no internal vocabulary, one phrasing per fact.
  • Each card closes with how it was decided: basis, what it read, how often it is wrong.
  • Status dots beside every section, a skeleton while the dossier builds, figures for review time, likelihood, evidence level, route and hazards, and the lineage drawing on the landing.