Medical devices and precision parts
Batch record and traceability software for medical device makers
Material lots that must link to the finished unit, checks that carry a name and a time, instruments with a calibration date, and an auditor who will ask for the batch record. FleekERP links material lots to units, records inspection results at the operation with the operator and the instrument used, and assembles the batch record while the work happens.
Book a demoBook a demo for your plant
45 minutes, run on your own stages and quality checks.
What slows medical device makers down
- Batch records are built after the factInspection results and operator names are collected into the batch record at the end, not as the work happens.
- Calibration dates live in a notebookNothing stops a check being done with an instrument that's past its calibration date.
- Tracing a unit to its lots is slowLinking a finished unit back to its material lots means pulling paper records from several departments.
How it works
How your floor runs on FleekERP
- 1OrderSales order with the part, revision, quantity and delivery dateProduction control
- 2RoutingOperations, work centres and the checks required at each oneProduction planning
- 3MaterialComponents and raw material issued by lot against the batchInventory and traceability
- 4ProductionCounts by operation, with the operator and the time on every entryShop floor apps
- 5InspectionResults against nominal and tolerance, with the instrument usedQuality control
- 6Release and dispatchBatch record assembled and released, delivery note and invoiceQuality and compliance
Built for medical device makers
- Lot to unit and backA finished unit traces to every material lot in it, and a material lot traces forward to every unit and shipment it reached.
- The instrument is on the resultAn inspection result records which instrument took it, so a calibration date is checked against actual use rather than a list.
- Batch record assembled as it runsThe record is built from what the floor entered, not typed up afterwards, so it is ready when the auditor asks for it.
Proof from other floors
Measured on real floors
None of our live customers are medical device makers yet. These factories are, and the same screens run your stages.
- Challenge
- OEM audit trails assembled from Excel, days per request
- Modules
- Production control, Traceability, Quality control
- Result
- Full lot trace in under 3 minutes. Excel traceability sheets gone.
- Challenge
- Planning took a full day; material over-consumption found after cutting
- Modules
- Production planning, Stock and BOM, Operator app
- Result
- Planning time down 60%. Over-consumption flagged while the roll is cut.
- Challenge
- Labour cost per order unknown; wages reconciled from bundle cards days later
- Modules
- Operator app, Production control, Cost per order
- Result
- Labour cost per order visible. Paper registers gone.
Cost and time
What it costs and how long it takes
- £4.50per employee login a month£22 per user login, annual termSee pricing →
- £3,700one-time setup, up to 100 loginsSetup and training at the stationHow setup works →
- 18 daysto your first production line liveOn scope agreed before you startWhat's included →
Questions from medical device makers
Are you validated for ISO 13485 or 21 CFR Part 11?
No, and we will say so on the call. FleekERP keeps an audit trail with the user and the time on every entry and produces the batch record from it. Validating that against your quality system is your process, not a claim we make for you.
Can inspection results be numeric with limits?
Yes. A characteristic carries a nominal and a tolerance. A value outside it fails the check and holds the batch.
Next step
See FleekERP on your own production flow
Bring your routings and quality checks. We set them up before the call, so the demo shows your own stages.