UDI
FDA traceability required
Life Sciences · Medical Devices
From 510(k) to commercial scale — without losing traceability along the way.
Medical device companies operate at the intersection of regulatory intensity, distribution complexity, and growth pressure. UDI compliance, lot-level traceability, quality system integration, and multi-channel revenue recognition don't simplify as you scale. Archer configures NetSuite so your financial infrastructure keeps up.
ISO 13485
QMS standard
21 CFR 820
Quality system regulation
Recall speed
Directly tied to lot data quality
Premier
NetSuite partner
Where device finance gets complicated
Fragmented systems create compliance gaps — and slow recalls.
When UDI data lives in one system, financial records in another, and quality events in a third, the organization is always one audit — or one recall — away from a very expensive reconciliation project. Real-time traceability, audit-ready controls, and revenue recognition for bundled device arrangements require an ERP configured specifically for device manufacturers.
UDI compliance requires traceability the system can't provide
FDA UDI requirements demand cradle-to-grave serial and lot tracking — from component receipt through patient use. When lot data is incomplete or siloed from financial records, recall execution is slow, documentation is incomplete, and regulatory exposure is real.
Fragmented systems directly delay recall response and increase regulatory exposure
Multi-channel distribution without unified revenue treatment
Distributor networks, direct sales, GPO contracts, and international channels each carry distinct pricing, commission structures, and revenue recognition requirements. Without structured order management, GTN calculations are manual and audit-prone.
Without real-time inventory tracking, device companies face overstocking, stockouts, and expired inventory — direct working capital impact
BOM and manufacturing COGS that don't match actuals
Standard cost variances, overhead absorption, and finished goods valuation require accurate BOM configuration and WIP tracking — whether devices are manufactured in-house, outsourced to a CM, or produced through a hybrid model. Approximations create margin distortions that compound over time.
Standard cost variance without BOM discipline leads to systematic COGS under- or over-statement
Quality events that don't connect to financial records
MDR filings, field corrective actions, and CAPAs have financial implications — recall costs, warranty reserves, inventory write-offs — that require coordination between QMS and ERP. When those systems are separate, the financial impact of quality events is always reactive.
Quality-to-finance reconciliation is a top close-cycle time sink for device finance teams
Built for device manufacturers and distributors
The modules that close the gap between compliance and finance.
Archer's purpose-built modules and NetSuite configurations address the specific workflows where device finance teams lose time — UDI traceability, quality event financial treatment, and distributor channel management.
Archer Module
eQMS Suite
Complete electronic quality management integrated within NetSuite — so MDR events, CAPAs, and field corrections automatically trigger the financial treatment they require, without manual coordination between separate systems.
Archer Module
EBR / DHR
Device history records maintained within the NetSuite environment — linking manufacturing data and component lot history to financial records, enabling UDI-compliant traceability and rapid recall documentation.
Archer Module
CAPA / Non-Conformance
Corrective and preventive action tracking with financial workflow integration — so recall cost accruals, warranty reserves, and inventory adjustments are initiated from the quality event, not discovered at close.
Archer Module
3PL Integration Connector
Bi-directional integration with 3PL warehouse partners for real-time lot-level inventory visibility, order fulfillment confirmation, and UDI-aligned shipment documentation — across domestic and international distribution nodes.
What becomes possible
Traceability that satisfies regulators and gives operations real visibility.
When UDI data, quality records, and financial systems share a single environment, the cost of compliance drops — and the speed of response to quality events increases significantly.
Hours
Not days — for recall identification
Recall execution that moves at the speed regulators expect
Lot-level traceability linked to customer shipment records means identifying affected units is a query, not a multi-day manual reconstruction. Distribution lists, return authorizations, and disposition documentation generated directly from NetSuite.
One
System for quality and finance
Quality events that trigger the right financial treatment automatically
CAPAs, field corrections, and MDR filings initiate inventory adjustments, warranty reserve entries, and recall cost accruals from within the same environment — eliminating the close-cycle reconciliation that previously consumed finance team time.
Clean
GTN and revenue recognition at close
Channel revenue that recognizes correctly from the start
Multi-channel pricing, distributor chargebacks, and bundled device-service revenue configured in NetSuite from contract execution — so revenue recognition at close is automated, not manually assembled from channel data exports.
Get started
Ready to build the financial infrastructure your device business needs to scale?
Schedule a discovery call with Archer. We'll assess your current environment and show you what purpose-built NetSuite looks like for medical device companies at your growth stage.