ERP for medical device makers in India: DMR and DHR, lot and serial traceability, document control, supplier qualification, recalls and audit readines...
Quick answer: ERP for medical device manufacturers manages BOMs and engineering changes, the Device Master Record (DMR) and Device History Record (DHR), lot and serial traceability, controlled documents, supplier qualification, quality inspections and recalls, linked to purchase, production, sales and accounts. It helps Indian device makers stay ready for ISO 13485 audits and Medical Device Rules inspections while controlling cost and delivery.
Updated: November 2026 · Written by Riya, Pothera ERP
Medical device manufacturing runs on records. Every device needs proof of how it was made, from which components, by whom and after which checks. When a field complaint or an audit comes, the question is never "do you have the records?" but "how fast can you show them?". Paper files and disconnected sheets make that answer slow and risky.
This guide is for owners, plant heads and QA heads of medical device and equipment manufacturers in India, from consumables and disposables to diagnostic and electronic equipment. It explains what device ERP must do, the compliance angle and how to choose one.
Short on time? See Pothera Medical ERP or book a 30-minute demo.
| Requirement | What ERP does |
|---|---|
| Design and BOM control | Multi-level BOMs with engineering change orders and approvals |
| Device Master Record (DMR) | Approved specifications, BOMs, processes and documents for each device |
| Device History Record (DHR) | Production records for each lot or serial: materials, steps, checks and release |
| Traceability | Lot and serial tracking from supplier to customer, with barcode or RFID |
| Supplier control | Supplier qualification, monitoring and inward inspection |
| Quality | Inspection checkpoints in receiving, production and dispatch |
| Document control | Controlled documents with versions and audit trail |
| Recalls and complaints | Find every affected lot, serial and customer quickly |
Pothera ERP is used by AOV Instromedix India, a provider of medical devices and solutions.
Audit coming up? Ask for a free traceability check. Pick one shipped device, and we'll show you how its full history would look in Pothera ERP.
Indian device makers work under the Medical Device Rules, 2017, regulated by CDSCO, and most follow ISO 13485 for their quality system. ERP doesn't replace the quality system, but it makes the records behind it complete and fast to retrieve:
It is ERP software for device manufacturers that adds DMR and DHR, lot and serial traceability, document control, supplier qualification and recall management to normal purchase, production, inventory, sales and accounts.
Yes. ERP keeps the records ISO 13485 auditors check, such as controlled documents, production and inspection records, supplier controls and traceability, complete and easy to retrieve.
Yes. Pothera Medical ERP maintains DMR and DHR linked to actual production, materials and inspections.
With lot and serial traceability, ERP finds every affected component lot, device and customer quickly, so recalls are faster and more precise.
Yes. Small device makers face the same documentation demands as large ones, and ERP reduces the manual work for small QA teams.
Yes. Pothera supports multi-location production and warehouse management with central traceability.
Pick one device you shipped recently. We'll show you its complete history, from components to customer, in Pothera ERP. Book your demo.
Related reading: ERP for pharma manufacturers · ERP for electronics manufacturing · Documentation and approvals with ERP