Introducing the New Packaging Management Module

September 2025 - Product Innovation / Compliance

Manage UDI, labeling, and packaging in a single integrated system designed to simplify compliance with MDR and streamline operations. Take control of packaging →

Compliance in the medical device industry requires strict control of packaging, documentation, and regulatory identifiers. Under MDR, this includes managing primary and secondary packaging together with Instructions for Use (IFU), Certificates of Conformance (CoC), and Unique Device Identifiers (UDI). The Packaging Management module streamlines this process, offering a single, integrated system that unifies packaging and documentation control while ensuring full regulatory compliance.

Managing Every Aspect of Packaging

Our original Label Management module was designed for basic labelling needs. The new Packaging Management module takes this further by consolidating all aspects of packaging management into a single, powerful, and fully integrated system. The Packaging Management module is available as an optional upgrade for labs that need UDI capabilities, multi-level packaging control, and integrated documentation management. It offers full backward compatibility, ensuring that existing label data and workflows carry over seamlessly. For labs with simpler requirements, the existing Label Management remains a reliable solution for simpler labeling needs.

1. EU MDR AND ISO 13485 COMPLIANCE

   Ensure packaging processes align with current regulatory requirements

2. RULES-BASED UDI MANAGEMENT

   Generate and manage UDI codes using structured logic

3. PRIMARY AND SECONDARY PACKAGING CONTROL

   Handle both packaging levels within a single environment

4. UNIFIED UDI AND PACKAGING TOOL

   Combine identification and packaging management in one system

5. SMOOTH UPGRADE FROM LABEL MANAGEMENT

   Transition seamlessly from the previous Label Management module

6. FLEXIBLE AND FUTURE-PROOF SOLUTION

   Adopt a scalable framework ready for evolving regulatory demands

Rule-Based Packaging Control

The Packaging Set gives laboratories precise control over how packaging is defined. It works as a rule engine, applying filters such as country, market, area, zone, or customer type to decide which components apply to each product. Every condition can trigger its own combination of elements, offering full flexibility with centralized oversight. This automation reduces errors, speeds up launches, and ensures packaging meets regulatory and quality standards in any market.

UDI in the Workflow

UDI Management is now fully integrated into Packaging Management, giving you complete control over how UDIs are created and printed. With rules-based logic, codes can be adapted to product types and markets, supporting even the most complex configurations in specialty contact lenses. The module also covers Fitting Sets, which present unique challenges under MDR. Since their labeling depends on QMS handling rather than standard orders, the system streamlines the process with flexible options to manage UDI labeling efficiently and compliantly.

Visual Packaging Designer

The module includes a new Packaging Designer, a WYSIWYG tool for both primary and secondary packaging. It lets users create layouts by combining fixed and variable elements such as order details, lens parameters, barcodes, images, and logos. Dimensions, positioning, and formatting are fully under control. Dynamic variables pull data directly from the FocalPoints database, auto-filling fields like serial numbers, patient information, and other order-specific details. This integration cuts manual input, reduces errors, and guarantees full traceability across all packaging.

One Solution for Compliance and Efficiency

The Packaging Management module brings packaging, labeling, and UDI together in a single system. It gives manufacturers one point of control to meet regulatory requirements, reduce complexity, and strengthen daily operations. More than just compliance, it empowers labs to stay agile, efficient, and prepared for the future.

The Packaging Management module is more than an update—it’s a strategic tool to stay ahead of evolving regulations, including complex UDI requirements. By centralizing and automating packaging, it streamlines operations and ensures full compliance.

Filippo Selden, CEO Advance