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Modules/Products & Materials/Product Management
Products & Materials

Product Management

Maintain a complete, centralized product registry with detailed specifications, classifications, and lifecycle status tracking. Ensure every product is properly documented with regulatory classifications, intended use statements, and links to all associated quality records.

Regulatory Context

EU MDR Article 18 — Unique Device Identification (UDI) system
ISO 13485:2016 §7.5.1 — Control of production and service provision
FDA 21 CFR Part 820.184 — Device History Record

Key Capabilities

What you get with the Product Management module.

Centralized product registry with regulatory classification and lifecycle status
Product specification management with revision control
Intended use and indications documentation for regulatory submissions
Product family and variant management with shared attribute inheritance
Traceability linking products to design records, risk files, and clinical data

Why It Matters

How Product Management helps your organisation.

Achieve full product traceability from design records through distribution
Simplify regulatory submissions with a centralised product registry
Reduce compliance gaps by linking every product to its classification and intended use

How It Connects

Product Managementdoesn't work in isolation. It connects seamlessly with other modules in MoniDoseQMS for full traceability across your quality system.

Ready to see Product Management in action?

Book a 30-minute demo tailored to your regulatory needs. Our team will walk you through how Product Management works within your specific compliance context.

More in Products & Materials

Explore other modules in the Products & Materials category.

Bill of Materials

Define and manage product bills of materials with multi-level component structures and version control. Maintain full traceability from finished products down to raw materials, ensuring accurate BOMs support manufacturing, quality, and regulatory requirements.

Material Management

Track and manage all raw materials, components, and consumables used in your products and manufacturing processes. Maintain material specifications, certificates of conformity, and supplier information in one place for complete material traceability.

Asset Tracking

Track and manage physical assets including equipment, tools, and fixtures across your facilities. Maintain complete asset records with location tracking, maintenance schedules, and qualification status for regulatory compliance.

Inventory Management

Manage inventory levels of raw materials, components, and work-in-progress with lot-level traceability. Ensure material availability for production while maintaining the quality controls and documentation required in regulated environments.

Finished Goods Inventory

Track finished products from final release through distribution with lot-level traceability and hold/release controls. Manage warehouse locations, shipping holds, and distribution readiness to ensure only approved products reach customers.

Internal Transfers

Document and track the movement of materials, components, and products between internal locations, warehouses, and production areas. Maintain chain-of-custody records and ensure transferred items retain their quality status throughout your facility.