Medical Devices Business Information Model

The Medical Devices Business Information Model maps the data entities that manufacturers, distributors, and quality teams manage across the device lifecycle — from design and regulatory classification through field use and post-market surveillance. Entities are grouped into foundational, transactional, and informational layers, with the relationships between them documented, in an editable Word document.

Device data doesn't behave like a normal product catalog. A single device model exists at three distinct levels — catalog number, lot, and serial or Unique Device Identifier — and regulatory traceability depends on keeping those levels separate rather than collapsing them into one SKU entity. Many devices, especially implantables, move through consignment inventory sitting at a hospital before any sale is recognized, which breaks a standard order-to-cash structure. And "customer" is really three different entities in disguise: the purchasing organization, the clinician who uses the device, and the patient it's used on — each with a different relationship to a complaint or adverse event record that has to trace back to a specific lot and forward to a CAPA or field action.

Inside the Model

• Foundational entities — device/catalog data, UDI structure, regulatory classification, facilities, suppliers
• Transactional entities — orders and consigned inventory, complaints, adverse events, CAPA, field actions/recalls
• Informational entities — post-market surveillance, complaint trending, lot-to-patient traceability
• Entity relationships across the model, captured in an editable Word document

Where It Gets Used

• Foundation for quality and regulatory systems tracing lot/serial data to complaints and field actions
• Reference for device master data management — catalog, UDI, and facility records
• Supports integration planning between ERP, quality management, and surveillance systems
• Starting point for modeling consignment and hospital inventory data

Built For

Suited to data architects, business architects, and IT and quality leaders at device manufacturers, distributors, and contract manufacturers building or replatforming quality, ERP, or surveillance systems.