Executive Summary
Relisys manufactures cardiovascular medical devices — products implanted in patients, where a manufacturer must be able to trace any unit back through production, materials and testing, and forward to where it went, as a condition of doing business.
With TEKROI as implementation partner, Relisys runs that obligation on SAP Business One: batch- and serial-controlled manufacturing, quality-linked release, and domestic and export distribution on one core — traceability as a system property rather than a documentation exercise.
About Relisys
Relisys Medical Devices is an Indian manufacturer of cardiovascular devices, serving domestic and international markets from its Telangana facility.
The Challenge: Device-Grade Traceability in Stent Manufacturing
Device manufacturing carries obligations most ERPs only gesture at:
- Lot and unit traceability — regulators and customers expect any device to be traceable both directions, instantly.
- Staged, controlled production — cleanroom stages, in-process checks and release protocols must be reflected in the system, not around it.
- Materials with pedigrees — critical inputs carry their own lot documentation into the product’s record.
- Domestic and export in parallel — different markets, documentation and pricing on one operation.
- Recall readiness — the ability to answer ‘which units, where’ is a capability you prove before you need it.
The Solution: SAP Business One for Medical Device Manufacturing
TEKROI implemented SAP Business One as Relisys’ manufacturing and distribution core:
Traceable Production
- Batch/serial-managed inventory through staged production orders, with material lots linked into every finished device’s genealogy.
- Quality release integrated into the flow — nothing ships that isn’t released.
Distribution
- Domestic and export order-to-shipment with market-appropriate documentation and pricing.
Finance & Costing
- Device-level costing and consolidated financials on the same core.
Implementation Journey
TEKROI’s fixed-scope methodology took the project from assessment to go-live through eight stages: assessment, blueprint, configuration, customization, data migration, training, go-live and ongoing support.
Results
- Two-way traceability on demand — from any device to its materials and tests, and from any lot to every unit shipped.
- Compliance in the flow — release controls live in the process, so conformance is how work happens, not an audit-time reconstruction.
- Recall readiness proven — ‘which units, where’ is a system query with a fast answer.
- One core for both markets — domestic and export business share process, inventory and books.
Why This Story Matters
Medical devices are the hardest test of an SME ERP: regulated, staged, serialized, exported. Relisys shows SAP Business One passing it — the reference for any regulated manufacturer weighing whether the platform can carry compliance-grade operations.
