Orthopaedic implant manufacturing
Every implant. Every operation. Every signature. One record.
MESvantage is the manufacturing execution and intelligence system built inside a live 250,000 † -knee-a-year orthopaedic plant in Ireland — and validated there, in production, under that site's ISO 13485 quality system. Audit preparation stops being an archaeology project.
- Serial
- Operation
- Gauge
- Result
- Signed
- Hash
- UTC
What the system writes for every operation, on every part. People sign; the system proves.
- Quality
- Production
- Metrology
- Training
- Intelligence
- Platform
- DHR
- FAI
- SPC
- NC
- CAPA
- OEE
- Genealogy
- E-signatures
- Audit trail
- Lot release
c5e2bd8e. Ardara Orthopaedics is a fictional manufacturer and every record shown is seeded
demonstration data — no part, person or customer here is real.
The problems every CDMO lives with.
- 01
Audit prep is a three-week fire drill
Every FDA or notified body visit means weeks of pulling records, chasing paper travellers, and reconstructing device history from spreadsheets and shared drives.
- 02
You can't see your floor in real time
Machine status, OEE, active jobs, operator positions — none of it is visible until someone walks the floor or checks a whiteboard at shift handover.
- 03
Your quality system is a shared drive
FAIs, NCs, CAPAs, incoming inspection results — scattered across SharePoint folders, email threads, and institutional knowledge that leaves when people leave.
On that last one
We looked across eighteen platforms and roughly three hundred sources in July 2026 and could not find another MES vendor with a named orthopaedic implant machining customer. If you can name one, tell us and we will publish it here. Every number on this site, with its source →
One platform, every system on your floor.
MESvantage sits at the centre of your manufacturing stack — ingesting data from ERP, quality, machines and metrology, and turning it into validated records, real-time intelligence, and customer-ready outputs.
Each customer runs in a dedicated deployment: separate compute, database and storage. Isolation is not a regulatory requirement, but it keeps your audit scope simple and your data unambiguously yours.
The gap nobody else fills.
- 01
Purpose-built for CDMOs
Not a generic MES retrofitted to medical. Every workflow — DHR, FAI, CMM, OEE, NCR, lot release — was designed for regulated contract manufacturing from day one.
- 02
Validation you execute, not author
IQ/OQ/PQ has been executed for MESvantage at our founding customer's site, under their quality system. You still own validation — no supplier can discharge it. We supply the protocols, test scripts, traceability matrix and executed reference evidence so your team executes rather than writes.
- 03
Production-grade
Running daily in an orthopaedic plant that is FDA-registered and ISO 13485-certified — the plant’s credentials, not ours. Every feature in the validated scope has run on a real production floor — not a lab, not a pilot, not a demo environment.
Patrick Byrnes
CEO, Croom Medical
Founder, MESvantage
We spent two years looking for an MES that understood a knee. Everything we found was a QMS pretending to be an MES, a platform we would have had to build ourselves, or a two-year programme priced for a company ten times our size. So we built it, we validated it, and we ran our plant on it. This is that system — not a version of it, not a demonstration of it. The same one.
A disclosure, because you would find it anyway. MESvantage Limited and Croom Medical share a founder and chief executive. Croom is our only customer to date, so this is a related-party reference and we describe it as one. What is not related-party is the record: the system has been in scope for external audits of an FDA-registered, ISO 13485-certified plant, and Croom's quality manager will take your call.
Every connected machine, every shift, on one screen.
Live ingestion from OPC-UA, MTConnect and Modbus. Machine state, utilisation and downtime reasons are captured as they happen and surfaced per cell, per work centre and across the fleet — with threshold and trend alerting on the signals your maintenance team already watches.
- Real-time OEE per cell, work centre, and fleet
- Downtime reasons captured by operators at the machine
- Threshold and trend alerting on temperature, cycle and feed
- Maintenance work orders drafted for a person to approve
- Before we quote, we survey your machines and tell you which can be read on day one
People sign. The system proves.
An assistant grounded in your own records. It answers using retrieval over your MESvantage data and links to the source record behind each statement. It is a read-and-draft tool: it cannot approve, sign, disposition or release anything.
- Your data is never used to train models — ours or a third party’s
- Retrieval is scoped to your tenant; answers link to the underlying records
- Drafts only — a qualified user reviews and signs; nothing takes effect without approval
- Barred in software from releasing product, dispositioning parts or closing a quality record
- Every response is written to the audit trail with its question, sources and model version
c5e2bd8e. Ardara Orthopaedics is a fictional manufacturer and every record shown is seeded
demonstration data — no part, person or customer here is real.
Every part. Every operation. Every signature.
Trace a single serial number from raw stock to dispatch in two clicks — assembled as the part is made, rather than reconstructed afterwards.
- Forward and backward trace from any lot or serial
- Raw material certificate bound to the parts it became
- Every operation, gauge and signature on the record it belongs to
- The device history record assembled as work happens, not afterwards
- Audit trail filterable to a single record, exportable as evidence
c5e2bd8e. Ardara Orthopaedics is a fictional manufacturer and every record shown is seeded
demonstration data — no part, person or customer here is real.
74 modules. Six domains.
Every module was written for regulated contract manufacturing, not retrofitted from a generic platform. Each one carries a label saying whether it is live in production today.
Quality
From incoming inspection to lot release — every quality record signed, traceable, and audit-ready under 21 CFR Part 11.
See modulesProduction
Real-time OEE, scheduling, and in-process documentation that eliminates paper travellers and floor clipboards.
See modulesMetrology
CMM results parsed automatically from Renishaw, Hexagon, and Zeiss — tolerance failures flagged before the part leaves the machine.
See modulesTraining
Operators can only run what they are trained on. Training is verified at start, record and sign — a gate that stops the work, not a matrix you maintain.
See modulesIntelligence
CEO-level visibility: machine utilisation, quality trends and energy spend, with threshold alerting — without a BI team or data analyst.
See modulesPlatform
Mobile PWA, digital signage, audit trail, e-signatures, and role-based access — the regulated infrastructure that makes the rest possible.
See modulesGet started
See exactly what MESvantage would look like in your plant.
A two-page summary of every domain, our compliance position, and the implementation plan. No form — it downloads straight away.
About the interface images on this page. They are screenshots of MESvantage running against a demonstration dataset — the real application, not illustrations of it. Ardara Orthopaedics is a fictional manufacturer and every record shown is seeded demonstration data, so no part, person or customer on this page is real. Each caption records the route, the build it was captured from, and the date.