ShopXpert medical device manufacturing software connects jobs, lot and serial records, inspections, calibrated equipment, suppliers, and training in one platform, so every component can be traced from raw material to shipment.
Swiss TurningWorkstation 2 · 500 / 500 complete
CompleteDeburr & WashIn-process check signed
CompletePassivationOutside process · PO linked to job
At SupplierLaser MarkingLot number marked on each part
Up NextFinal Inspection & PackInspection form with signature
PlannedMedical device suppliers are audited on what they can prove. Incomplete lot history, uncalibrated gauges, or untrained operators put customers and contracts at risk.
Every lot, material certificate, operation, and supplier must be traceable when a customer or auditor asks.
ISO 13485 and customer quality agreements demand controlled documents, inspections, and auditable records.
Gauges and machines need documented calibration and maintenance before they touch production.
Operators must be trained on current procedures, with records that prove it.
Tie material certifications, lot numbers, operations, inspections, and outside processes to the job, so the complete history of every component stays in one record.
Continue the serial sequence from your current system and use QR codes to identify jobs, materials, and orders at every step on the floor. Everything connects to the same manufacturing ERP your office uses for quoting, purchasing, and scheduling.
Each step adds evidence to the same job history, so quality, purchasing, and the shop floor can answer audit questions quickly.
Start with the modules you need today, from manufacturing ERP to CMMS and preventive maintenance, and add more as programs grow without rebuilding your data foundation.
Trace every lot and serial number from raw material to finished component, with history that stays on file.
Build inspection forms with pass or fail checks, photos, and signatures, and manage non-conformances against the job.
Track calibration due dates and keep expired gauges out of production through connected vending and tool control.
Schedule recurring machine maintenance and keep photo and signature proof with each equipment record.
Store supplier certifications and get alerts before they expire, with RFQs and purchase orders tied to each job.
Publish procedures and train operators in the Academy module to support ISO 13485 and customer audits.
Medical customers expect documented equipment control. ShopXpert schedules preventive maintenance, captures photo and signature proof when work is done, and tracks gauge calibration dates so expired tools are removed from access until they are recalibrated.
Explore how ShopXpert connects lot traceability with manufacturing ERP workflows, calibrated equipment, training records, and the wider platform.
Built with manufacturers since 2020 and rated highly by the people who use it every day.
Answers for medical component suppliers evaluating traceability, quality records, equipment control, and training.
Medical device manufacturing software connects production, quality, and supplier records so component suppliers can trace every lot, prove inspections, and pass customer and ISO 13485 audits. ShopXpert combines manufacturing ERP, lot traceability, inspection forms, calibration control, maintenance, and training in one platform.
Yes. ShopXpert tracks lot and serial numbers, inspection reports, and non-conformances, giving traceability from raw material to finished part. Material and supplier certificates can be attached to the job.
ShopXpert supports ISO-driven quality workflows with inspection forms, controlled documents, supplier certificate tracking, gauge calibration control, and Academy training records.
Yes. Calibration due dates are tracked for each gauge, expired tools can be restricted until recalibration, and preventive maintenance tasks keep photo and signature proof with the equipment record.
Procedures, instructions, and training content live in the Academy module, so you can show which operators were trained on which documents.
Book a focused walkthrough built around your medical components, routings, inspections, and quality requirements.
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