ANZCARE — Transforming Medical Device Compliance with Automated Serial Number Tracking

Client Overview

ANZCARE Limited, based in Waikanae north of Wellington, is a specialist medical device manufacturer that designs and produces the DRI Sleeper range of bedwetting alarms. Founded and operated by Karen and Stephen, the company has built a reputation for innovative wireless technology, having developed the world's first two-piece wireless bedwetting alarm. With their flagship products—the Eclipse and Excel alarm systems—selling approximately 12,000 units annually, ANZCARE has established a significant global presence across multiple international markets including Australia, the United Kingdom, Europe, and the United States.

The company operates an extensive multi-channel sales operation, managing four separate Shopify storefronts and seven different Amazon regional marketplaces, alongside eBay and third-party fulfilment partnerships. As a medical device manufacturer, ANZCARE faces stringent regulatory requirements for tracking every device serial number to ensure compliance with safety standards and enable rapid response in the event of product recalls.

The Challenge

Despite their success in product innovation and market expansion, ANZCARE's back-office operations were struggling under the weight of manual processes. Amanda, who manages dispatch operations, was spending hours each day tracking serial numbers using a fragmented system of printed sheets and multiple spreadsheets scattered across different files and folders. Every single order required manual data entry, with staff members handwriting serial numbers on printed order forms, then transcribing that information into various spreadsheets for record-keeping.

This manual approach created several critical business risks. As a medical device manufacturer, ANZCARE is legally required to maintain meticulous serial number tracking for regulatory compliance and safety recall capabilities. Manual data entry introduced the risk of allocation mistakes, duplicate assignments, and inventory discrepancies that could have serious compliance implications. Furthermore, Karen and Stephen lacked real-time visibility into inventory levels and order fulfilment status, making it difficult to make informed business decisions or quickly respond to supply chain issues.

The complexity was compounded by ANZCARE's multi-channel sales operation. Orders flowing from four different Shopify sites, seven Amazon regions, eBay Australia, and third-party fulfilment partners all required manual reconciliation. Staff had no centralised system to track which serial numbers had been allocated to which orders, or to monitor the status of devices through their lifecycle from manufacturing through to delivery.

The Solution

Automate AI developed a comprehensive, cloud-based serial number tracking system that replaced ANZCARE's entire manual process with an automated, integrated solution. The custom-built web application centralised all serial number management into a single platform accessible from any device, with barcode scanner integration for rapid data entry and real-time synchronisation across all sales channels.

The system was designed specifically for ANZCARE's product line, handling the unique pairing requirements of their Eclipse and Excel alarm systems. Standard products require one base unit paired with one sensor, while specialty packages like Eclipse Plus and Excel Special need two base units paired with one sensor. The platform automatically manages these pairing relationships and tracks component versions including transmitter and receiver firmware and sensor batch numbers.

Integration with ANZCARE's four Shopify sites and seven Amazon marketplaces was achieved through automated order synchronisation. The system pulls orders automatically from each sales channel, intelligently allocates available serial numbers based on product type and inventory status, and generates shipping documentation with country-specific tax rules and multi-currency support. Amanda can now use a barcode scanner to quickly assign serial numbers to orders, with the system automatically validating formats, checking availability, and updating inventory status in real-time.

For Karen and Stephen, the platform provides a comprehensive dashboard with real-time inventory metrics, order fulfilment status, and activity feeds. Advanced reporting capabilities allow them to analyse sales performance across different channels, track product trends, and generate compliance reports with complete audit trails showing the full lifecycle of every device from manufacturing through to delivery or return.

Results and Impact

The implementation of the automated serial number tracking system has transformed ANZCARE's operations, delivering immediate and measurable improvements across the business. Amanda's daily workload has been dramatically reduced, with the elimination of manual spreadsheet work and printed order forms freeing up hours each day that can now be focused on higher-value dispatch coordination and customer service activities.

The system has eliminated the compliance risks associated with manual data entry. Every serial number allocation is automatically validated and recorded with a complete audit trail, ensuring ANZCARE can instantly respond to any regulatory enquiries or safety recall requirements. The automated validation prevents duplicate assignments and inventory discrepancies, giving Karen and Stephen peace of mind that their medical device tracking obligations are being met with enterprise-grade accuracy.

The platform's multi-channel integration has streamlined operations across ANZCARE's complex sales network. Orders from four Shopify sites, seven Amazon regions, eBay, and fulfilment partners all flow into a single system, with automated synchronisation ensuring inventory levels are always accurate and up-to-date. The real-time dashboard and reporting capabilities have provided Karen and Stephen with unprecedented visibility into their business performance, enabling data-driven decision-making and strategic planning for continued international expansion.

Conclusion

This case study demonstrates how custom automation solutions can transform operational efficiency whilst ensuring regulatory compliance for medical device manufacturers. For ANZCARE, the transition from manual spreadsheets to an integrated, cloud-based tracking system has not only eliminated hours of daily administrative work but also provided the scalability and oversight needed to support their growing global presence across multiple sales channels and international markets.