Medical device manufacturing software
Serial and lot traceability, device history records, and audit-ready documentation for medical device manufacturers. Supports FDA and ISO compliance without the complexity of enterprise ERP.
30-day money-back guarantee · Go live in 3–6 weeks
The challenges medical device manufacturers face
FDA and ISO compliance demands complete documentation
FDA 21 CFR Part 820 and ISO 13485 require device history records, production documentation, and full traceability for every device you manufacture. Most small device makers still manage this on paper or in disconnected spreadsheets.
How Brahmin solves it
Digital device history records generated automatically for every production run. Component lots, serial numbers, operator records, and inspection data captured at the time of production — not reconstructed before an audit.
A field safety action without traceability is a nightmare
When a component fails or a quality issue surfaces post-market, you need to know within minutes which devices are affected, which customers received them, and which component lots were used. Without traceability, that investigation can take weeks.
How Brahmin solves it
Full forward and backward traceability from component lot to finished device serial number to customer shipment. Generate recall-scope reports in minutes — know exactly which devices and customers are affected.
Audit readiness shouldn't require a scramble
Whether it's an FDA inspection, a notified body audit for CE marking, or a customer quality audit, you need production records, component traceability, and CAPA documentation at your fingertips — not buried in filing cabinets.
How Brahmin solves it
All production records, component traceability, and quality data are searchable and exportable. Pull device history records, lot genealogy, and supplier documentation in seconds — so audits become routine, not emergencies.
Everything you need to run your medical device business
Serial & lot traceability
Full forward and backward traceability from component lot to finished device serial number. Recall-scope reports in minutes.
Device history records
Automated DHRs for every production run — component lots, serial numbers, operator data, and inspection results captured at time of production.
Component inventory tracking
Real-time visibility into component stock levels across all locations. Track by lot number, serial number, and expiration date.
Multi-level BOMs
Manage complex device assemblies with multi-level bills of materials. Track sub-assemblies, components, and raw materials with full cost rollup.
Quality control & inspection
Record inspection results and quality checks at receiving and production. Flag non-conformances before they reach customers.
Supplier traceability
Track which supplier lots went into which finished devices. Maintain approved supplier lists and attach certificates of conformance to receiving records.
Warehouse & bin management
Organize components and finished devices by bin location. Controlled storage areas, quarantine zones, and clean room inventory tracking.
MRP & demand planning
Know what components to order and when. Automatic shortage alerts and reorder points keep production running without overstocking.
Mobile barcode scanning
Scan components at receiving, during production, and at shipment. Eliminate manual data entry errors with real-time mobile scanning.
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Common questions about Brahmin for medical device manufacturers
Does Brahmin Solutions support FDA 21 CFR Part 820 requirements?
Brahmin supports the operational requirements of FDA 21 CFR Part 820 (Quality System Regulation) — including device history records, lot and serial traceability, production records, and component tracking. Brahmin is a manufacturing and inventory platform that provides the documentation infrastructure your quality system needs. Full QMS compliance requires additional procedures and controls beyond what any inventory software provides.
Can Brahmin help with ISO 13485 documentation?
Yes. Brahmin creates digital production records for every device manufactured, capturing component lot numbers, serial numbers, operator information, and inspection results. These records support the documentation requirements of ISO 13485 for quality management in medical device manufacturing. Records are searchable, exportable, and audit-ready.
How does Brahmin handle device history records (DHRs)?
Every production run in Brahmin generates a complete device history record — components used (with lot and serial numbers), production steps completed, operator records, and quality inspection results. DHRs are linked to specific device serial numbers, so you can trace any individual device back to its full production history in seconds.
Does Brahmin support serial number tracking for medical devices?
Yes. Brahmin supports both serial number and lot number tracking at every stage — from component receipt through production to finished device shipment. Each serial number carries its full genealogy: which components were used, when it was produced, who handled it, and where it shipped. This is essential for field safety corrective actions and recalls.
Can Brahmin generate audit trail reports for FDA inspections?
Brahmin maintains a complete audit trail of inventory movements, production activities, and document changes. When an FDA inspector requests production records for a specific device or lot, you can pull the full history — component traceability, production records, quality checks, and shipment details — in minutes rather than days.
Ready to simplify your medical device operations?
Join 300+ manufacturers who switched from spreadsheets to a single source of truth. Go live in 3–6 weeks with a dedicated implementation manager.
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