Medical Device Manufacturing ERP A batch record built as the work happens.
Record material lots, checks, operators and instruments at each operation, ready for your auditor.
- Lot to device trace
- Instrument on every check
- Audit-ready batch records
Book a 45-minute demo
Set up on your own production flow.
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 medical device makers run on FleekERP
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.
- Material lot
- Production
- Process parameters
- QC
- Batch record
- Finished device
- 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.
None of our live customers are medical device makers yet. See the factories that are, and what they report.
Related to medical device makers
Questions from medical device makers
What is medical device ERP?
Medical device ERP serves makers of devices and precision parts, where each finished unit must trace to its material lots and every check needs a name, a time and a calibrated instrument. It plans and records production by batch, links material lots to units, records inspection results against tolerance, and assembles the batch record from what the floor entered.
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.
How is the batch record created?
From what the floor enters as the work happens: counts by operation with the operator and the time, the material lots issued and inspection results against nominal and tolerance. The record is assembled and released before dispatch, ready when an auditor asks.
How is instrument calibration tied to inspections?
Each inspection result records which instrument took the measurement, so a calibration date is checked against the instrument's actual use rather than a separate list.
Next step
See your material lot to finished device flow on FleekERP
Start with the problem you know best: batch records are built after the fact. We set up your stages before the call, so the demo runs on your floor.