Tools · Product
Vital.Expert Regulatory Intelligence for Digital Health
LiveClassify a digital therapeutic against FDA product codes and EU EMDN, pull pathway precedents and predicate chains — as the registers hold them, not as the model recalls them.
- Reads
- FDA 510(k) / De Novo summaries, EMDN / GMDN, stored pathway rows
- Returns
- Product-code classification, predicate chains, pathway precedents, register watches
- Runs inside
- Brief, Panel, Analysis
- Gaps
- Marked when a code, predicate level or jurisdiction is missing in store
Two routes: open this marketplace card to compare, then mint a personal key at /connect?product=regulatory-dh. Paste the Bearer key into Claude or any MCP host. Free plan: 100 counted calls. It brings attributed records in; it does not invent silence.
When to use it
You need the regulatory placement of a digital therapeutic — FDA product code, EU EMDN, precedents and predicates — from the register, not from model memory.
Regulatory and digital-health strategy leads who put pathway facts into Briefs before a submission or board decision.
What you get
- Classification from record. FDA product code, regulation number and EMDN / GMDN labeled from stored rows or taxonomy — each source tagged.
- Precedents without invention. Prior decisions for a product code or EMDN software class, with counts by pathway and year where the store has them.
- Predicate chain as published. Up to five levels from the FDA summary, with [GAP] where a parent is missing.
What it will not do
- It does not invent product codes, EMDN assignments or predicate parents.
- It does not issue a submission strategy or Notified Body opinion.
- It does not replace qualified person or affiliate regulatory sign-off.