V5 Ultimate
AI medical device manufacturing softwareAI-powered

AI-assisted builds. Inspected. On record.

AI reads component paperwork, spots recurring NCRs and plans components, while people approve every record. Connect component lots, assembly steps, inspections and labels in one device production record, with training, calibration and NCR/CAPA alongside.

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Technician in a cleanroom suit holding up a small device component while checking a tablet at an assembly lineCleanroom device assembly and inspection bench with lighted magnifier and fixtureTechnician in hooded cleanroom coverall, mask, glasses and gloves carrying a tray of sealed sterile device pouches
Why start now

The cost of waiting

Five reasons not to put it off.

Paper travellers hide gaps.

A missed inspection or an old drawing revision stays buried until review, audit or a field complaint.

Start your free trial 7 days free. No card required.
Where V5 fits

Keep your ERP. Run the floor in V5.

Add warehouse and quality when you're ready.

Your ERP
WarehouseV5 or yours
ProductionV5 Ultimate
QualityV5 or yours
Lab instruments
Scales
Scanners & printers
Sensors & IoT
And more
Your devices, your choice. Connections confirmed for your setup.
How it works

From component delivery to shipped device.

  1. Illustration: component cartons beside a tablet capturing lot details
    01
    Components received

    Capture supplier lot and certificate details for a person to confirm before use.

  2. Illustration: an assembly bench with a fixture beside a tablet listing signed steps
    02
    Build to the current revision

    Operators follow the released work instruction; each step is signed.

  3. Illustration: a small device beside a tablet showing a measurement inside the limit bandMEASURED mm24.98Target 25.00 ± 0.05settling…STABLEIn tolerance
    03
    Inspect and measure

    Record inspection results against limits, with the instrument's calibration status shown.

  4. Illustration: an inspection microscope beside a tablet showing a reviewer signature
    04
    Review the device record

    Quality reviews the completed production record before release.

  5. Illustration: sealed device pouches beside a tablet showing a label with a barcode
    05
    Label and ship

    Print labels from the approved design and link each shipment to its build.

Each record stays linked by lot, for example LC-90412 → CMP-1177 → WO-3318 → LOT-24-118 → SHP-4402. People make the quality and release decisions; V5 keeps the evidence together. See inventory & traceability

V5 AI

AI that sees it coming

It predicts and flags. Fixed rules decide. People sign.

How AI helps medical device makers

Predicts demand before it hits.

Forecasts device demand and tunes component reorder points.

See V5 AI Every AI output is a draft. A qualified person reviews and signs before anything is filed or released.
One platform

More than assembly. Run the whole quality system.

Non-conformances, documents, equipment and suppliers sit in the same system as your builds.

Page 13 of the guide: A person releases. The record shows why.Page 4 of the guide: New words for an old job, since February 2026Cover of The Medical Device Production Guide by V5 Ultimate
Free guide

The Medical Device Production Guide

Built to revision. Inspected. On record.

32 pages · 4 worksheets · 15 primary sources

Inside
  • What the QMSR changed in February 2026
  • Supplier to finished build
  • Inspect, review, correct
  • Labels, UDI and traceability
  • Evidence map and four worksheets

Free. Just your name and email, and it downloads instantly.

We use your details to handle this request. Privacy policy. Practical orientation, not legal advice; your quality unit decides which rules apply.

Reviewing a supplier for GxP records? See backup, recovery and resilience and the security procurement reference.

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How would this work in your facility?

Pick a question or write your own. It opens in the assistant for you to edit before sending.

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7-day free trial, no card required. No email needed to ask.

Smiling medical devices team member in full protective clothing using a tablet on the production floor
Your team makes the calls. V5 keeps the record.