For medical device
Answer every clinician with a rep that stays inside the IFU.
Device promotion, FDA- and Health Canada-bound. On web and Telegram, a device ZenRep is gated the same way a drug ZenRep is — kept inside the approved indications for use, off-label use claims refused, malfunction and adverse-event reports routed to your vigilance team, and every turn logged for your compliance team, before it reaches the clinician.
Three teams, one page — each sees the part they own.
Consistent answers across the whole install base.
Cover every clinician and biomedical engineer with consistent, approved product answers across the install base — the same accurate response whether it is a launch account or a decade-old install. Coverage stops being a function of how many field reps you can put on a plane.
IFU-bounded. No off-label use claims. Malfunctions routed, not triaged.
Answers stay inside the approved indications for use; off-label use claims are refused at the fail-closed pre-send verifier, with deterministic per-class refusal templates. A reported device malfunction or adverse event stops the sell and routes to your vigilance and complaints team, and every turn lands in an inspection-ready audit trail. FDA device-promotion framing, enforced in code.
The same trust spine as the rest of the platform.
Data residency in ca-central-1, tenant isolation enforced at the database, and an append-only per-turn audit record of every claim the agent made and what it was grounded against. Our data-handling and model-training policy, subprocessors, and a security contact live on the trust page.
Read the trust & security postureThe gate, in device-promotion terms
On the gated text channels — web chat and Telegram — every reply is constructed and checked before it reaches the clinician. For a device, that means:
Corpus-grounding
A ZenRep answers only from the approved materials you load — the IFU, technical specifications, approved claims. There is no general-model answer underneath.
Off-label refusal, fail-closed
Structural refusals (pediatric-on-adult, cross-tenant) fire before any model runs. Off-label and out-of-indication use claims are refused at the fail-closed pre-send verifier, with deterministic per-class refusal templates — a reply that cannot be grounded on-label is never improvised.
Malfunction & adverse-event routing
When a clinician reports a device malfunction, injury, or adverse event, a ZenRep stops selling, acknowledges it, and routes the report to your vigilance and complaints team — it never tries to triage or resolve the safety issue itself.
Inspectable audit trail
Every turn is written to an append-only record with database-level tamper protection; reconstruct any conversation and export CSV for an inspector.
Watch the gate work
Put the gate to the test yourself — ask about an unapproved use, push on a comparison the data does not support, and read the receipt. The live demo runs the real pre-send gate on every reply; today it runs against a fictional drug corpus (Veltarin, shown for demonstration only), and the same class-discriminated gate enforces device rulesets on the gated text channels.
Bring your regulatory team to the table.
A demo runs against a corpus that looks like yours, with your FDA device-promotion questions front and center.