Manufacturing ERP · Specialized Manufacturing
ERP for Medical Devices
Medical devices demand unit-level accountability: which lot, which components, which tests, delivered where. ERPKaro keeps lot and serial traceability with QC documentation aligned to Indian MD-rules expectations.
01
- Lot and serial traceability per device
02
- In-process and final QC documented per lot
03
- Sterile and controlled stock states enforced
04
- Distribution records per lot for vigilance
What slows medical devices operations down
01
Device history files take days to compile
Auditors ask for a lot’s full history and the answer is assembled from registers and binders.
How ERPKaro handles it
Components, production steps, QC results, and dispatches accumulate on the lot, queryable in minutes.
02
Component swaps go unrecorded
A substituted component never reaches the device record, undermining traceability claims.
How ERPKaro handles it
Production orders consume specific component lots, so substitutions are visible in the record.
03
Vigilance reporting outruns your records
A field complaint requires knowing every recipient of a lot, fast; ledgers cannot answer fast.
How ERPKaro handles it
Lot-wise dispatch history answers distribution queries instantly for vigilance and recalls.
04
Sterile stock mixes with unreleased stock
Released, in-test, and rejected lots share storage with only labels between them.
How ERPKaro handles it
System-enforced stock states keep unreleased lots unavailable for picking or dispatch.
How medical devices teams run ERPKaro
- Production Order Management. Device lots consuming recorded component lots
- Quality Control (QC). In-process and final inspection per lot with results
- Handling Units Management. Serialized units where unit-level history is required
- Inbound Load Management. Component lots received into inspection-hold
- Document Management. Test reports, IFUs, and dispatch documents per lot
- Return Order Management. Field returns logged with unit history
Built for Indian compliance
CDSCO MD rules alignment
Lot histories and distribution records on demand
GST e-invoicing & e-Way Bill
Compliant dispatch documents per consignment
ISO 13485-style records
QC and production documentation per lot
Frequently asked questions
Can ERPKaro maintain device history per lot?
Yes. Component lots, production steps, QC results, and dispatches accumulate on the lot record and are retrievable in minutes.
Does it support serial-level tracking?
Yes. Where unit-level accountability is needed, serialized handling units carry per-unit history.
How does it help with vigilance and recalls?
Lot-wise dispatch records answer distribution queries instantly, so notifications reach the right recipients fast.
Are unreleased lots blocked from dispatch?
Yes. Stock states are enforced: lots in inspection or rejection cannot be picked or shipped.
Is it suitable for both Class A and higher-class devices?
Yes. The traceability depth scales with your process: batch-level for simpler devices, serial-level where required.
More specialized manufacturing manufacturing
See your medical devices operation on ERPKaro
Walk through your workflows with our team, or start a 7-day free trial and explore at your own pace.