ERP for Singapore medical device manufacturers
Custom ERP for medical device manufacturers in Singapore. Device history records, ISO 13485 QMS, UDI tracking, CAPA management, and HSA product registration document control.
What we hear from medical devices operations directors.
Device History Records assembled manually per lot or serial number
ISO 13485 document control relies on shared folders with naming conventions
CAPA tracking in spreadsheets with no automatic escalation
Label control — wrong label version reaching production floor
Post-market surveillance data not linked to production records
Deep dives for medical devices.
ERP for Medical Device Manufacturers in Singapore
Device History Record management, ISO 13485 QMS workflow, HSA Medical Device Administration documentation, CAPA tracking — the ERP requirements Singapore medical device manufacturers need that standard systems miss.
Read →Quality Management in Manufacturing ERP: How Singapore Manufacturers Build the Audit Trail
Incoming inspection, in-process QC, first-article approval, NCR tracking, certificates of conformance, and supplier quality scoring — how QC integration in manufacturing ERP catches defects early and builds the audit trail customers require.
Read →Inventory Traceability for Singapore Manufacturers: Lot, Serial, and Expiry Tracking
Lot traceability, serial number tracking, expiry date control, and recall readiness — the traceability gaps that ABSS and Xero cannot close, and what a purpose-built system handles end to end.
Read →ERP Security and Backup for Singapore Manufacturers: What You Actually Need
Access control, audit trails, backup strategy, cloud versus on-premise security, PDPA compliance, and the customer security requirements that are increasingly non-negotiable in Singapore manufacturing supply chains.
Read →Systems medical devices companies typically evaluate.
Medical Devices ERP questions.
What is a Device History Record and how does the ERP handle it?+
A Device History Record (DHR) is the complete manufacturing record for a medical device — every material lot used, every process step performed, every inspection result, every operator involved. The ERP generates the DHR automatically from production data, eliminating the manual assembly that typically takes hours per batch.
Can the system support ISO 13485 compliance?+
Yes. Document control with version management and approval workflows, CAPA tracking with automatic escalation and effectiveness verification, supplier qualification records, training records linked to operator authorisation, and management review data — all maintained in the system with full audit trail.
How does UDI tracking work?+
Each device or device package receives a Unique Device Identifier at production. The UDI is linked to the DHR, enabling full forward and backward traceability. The system maintains the UDI database required for regulatory submission and supports label generation with UDI barcodes.
Similar manufacturing sub-sectors.
What would a custom medical devices ERP cost?
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