vibe·val

IEC 62304 validation in seconds, not hours.

A software change in an FDA-regulated environment shouldn't take a Quality Engineer half a day. Submit a diff, pick a risk class, get a CSA-aligned validation result with audit-ready attestation.

Get started I have an account →

How it works

POST /v1/validate
Authorization: Bearer csa_...

{
  "framework": "iec-62304",
  "risk_class": "B",
  "change_type": "modification",
  "diff": "...",
  "context": "Patient monitoring display update per REQ-042"
}

You get back a structural compliance verdict, a CSA-style validation rationale generated by the engine, and a SHA-256 attestation of the inputs and result. The hash goes in your Design History File.

Pricing

Class A check

$0.50

Class B check

$2.00

Class C check

$5.00

Buy credits in $20 to $500 packs. No subscription. View packs →

Status

Private beta. Email for access.