AI software for medical device manufacturers

AI software for medical device manufacturers.

Traceability the FDA can follow, CAPA that closes, training records that hold up. CitrusWeb builds software that makes compliance a byproduct of running the shop instead of a second job.

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6.8–9.4%
of sales is the medical device industry's total direct cost of quality, two-thirds of it cost of POOR quality (McKinsey)
~56%
of FDA device surveillance inspections end in required or voluntary corrective action (FDA 2015 data: 46% VAI + 10% OAI)
Feb 2, 2026
the QMSR (21 CFR 820 aligned to ISO 13485) took effect, with no transition grace period

Sources: McKinsey cost-of-quality research; FDA inspection data; FDA QMSR final rule. A McKinsey-documented eDHR/MES rollout eliminated documentation errors entirely and cut noncompliance reports 41%.

// Where AI helps in your shop

Where AI helps in 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.

Read the manufacturing brain drain, quantified, see CitrusWeb Works, or start at AI software for manufacturing.

// Questions shops actually ask
Is this a full eQMS?+
No, and we'll say so. CitrusWeb builds the record-keeping and workflow layer that small device shops actually need first; if you outgrow it into a full eQMS, your data comes with you.
How does the AI handle regulated records?+
The AI assists and a human approves. Every AI-touched record shows what was proposed and who accepted it, so the audit trail includes the AI itself.
Do you replace our ERP?+
No. We run beside it and fill the traceability and quality gaps around it.
What does it cost?+
Flat monthly per shop, never per seat, so quality, production, and the floor all work from the same record.
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See it running on your business, not a slide deck.

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