admin 7th August 2025

As global regulations tighten around medical device identification and traceability, achieving UDI compliance has become a critical mandate for manufacturers. At Katalyst Engineering, we specialize in integrating compliance requirements into engineering workflows without compromising product performance or process efficiency. This case study explores how we partnered with a leading medical device manufacturer to deliver a seamless, end-to-end UDI compliance solution that ensured regulatory alignment, reduced documentation efforts, and protected operational continuity.

Client Requirement Overview

A prominent medical device manufacturer approached Katalyst Engineering to enable end-to-end compliance with UDI (Unique Device Identification) regulations. With growing global regulatory pressure from bodies like the FDA and EU MDR, the client needed a comprehensive solution that addressed:

• Direct Part Marking (DPM) on complex reusable devices
• Labeling and packaging standardization
• Documentation support and lifecycle management
• Seamless PLM and ERP integration without impacting existing workflows

The challenge required technical expertise in both engineering and compliance, ensuring the solution didn’t disrupt production or affect product functionality.

Solution Implemented: A Structured, Phased UDI Compliance Framework

Katalyst Engineering deployed a compliance-driven engineering approach, following a detailed six-phase process that ensured complete traceability, documentation accuracy, and systems compatibility.

1. Study Product Geometry

• Assessed medical device structures to determine optimal locations for UDI marks without compromising usability or sterilization.

2. Define UDI Marking & Placement

• Finalized size, location, and format for DPM to ensure durability and regulatory acceptance.

3. Design Labeling Processes

• Created standard labeling templates aligned with industry and region-specific UDI requirements.

4. Update Parts & Assemblies

• Incorporated DPMs and UDI details into existing CAD models and technical documentation.
• Modified device BoMs and master records for compliance alignment.

5. PLM and ERP Updates

• Integrated UDI attributes into PLM workflows and ERP data to support real-time traceability and audit readiness.

6. Documentation & Testing

• Delivered validation-ready documentation, test specs, and UDI compliance templates.

Tools & Technologies Used

• CAD software
• PLM and ERP platforms
• Microsoft Office
• UDI data validation and barcode tools

Deliverables

• Fully formatted UDI labels and templates
• Updated CAD drawings and 3D models
• Test specifications for DPM durability and barcode readability
• PLM and ERP documentation for regulatory submissions and audits

Value Delivered by Katalyst Engineering

100% Compliance Achieved

All targeted devices were updated to meet UDI standards, supporting seamless approval by FDA and international bodies.

No Impact on Functionality

Katalyst ensured that marking and labeling did not affect the device’s usability, sterilization, or manufacturing process.

Efficient Systems Integration

UDI data was fully integrated into the client’s existing PLM and ERP systems no need for costly platform migration or new software investment.

Why Katalyst Engineering?

This project demonstrates Katalyst Engineering’s strength in compliance-focused mechanical and systems engineering. By combining technical precision with regulatory expertise, we deliver future-ready solutions that help medical device manufacturers stay ahead of global requirements.

Whether it’s UDI compliance, document lifecycle management, or smart system integrations, we bring the strategy, software, and execution needed to simplify complexity—and drive measurable ROI.

Conclusion:

Katalyst Engineering’s collaboration with the medical device manufacturer not only ensured full UDI compliance but also demonstrated how regulatory requirements can be transformed into strategic engineering advantages. Through a structured approach, detailed CAD and PLM updates, and smart integration into existing systems, we delivered a future-proof solution with zero disruption to operations.

This success reflects our commitment to helping regulated industries navigate complexity with confidence combining technical accuracy, process optimization, and compliance expertise to unlock long-term value.

Explore how Katalyst Engineering can support your medical device organization in achieving compliance without complexity.