AI software for medical device manufacturers.

Traceability by default

Lot and device history captured as work happens, so the record exists because the job ran, not because someone filed it.

CAPA with owners and deadlines

Corrective actions tracked as workflows that close, with the evidence chain intact.

Training evidence that holds up

Competence records tied to procedures and revisions, ready before the audit, not assembled the week of.

Ask your records anything

An AI assistant grounded in your own quality records: which lots used that material, which CAPAs touch that line. It retrieves; it never invents.

Nearly 100 opportunities for a documentation error every day in one McKinsey-documented case. Paper batch records are the classic source of the 483 that starts with a missing signature.

Corrective action is the most-cited area in external quality audits. A CAPA that lives in a document nobody owns is a CAPA that does not close.

Document-control failures under 21 CFR 820.40 are a top 483 category: staff unknowingly using an outdated form because the spreadsheet lagged the revision.

Real capability, but validation-heavy and priced for scale. 69 percent of quality leaders in one 2025 survey doubt their QMS will scale; the small device shop needs the record layer first, not the whole suite.