Redefining medical device labeling to meet regulations, control costs, and scale operations in an evolving landscape
100%
W.L. Gore achieves 100% label accuracy
70%
Quest Medical reduces label turnaround time by 70%
Our goal was to implement an integrated label management process that guaranteed accurate labels and data integrity.
Patrick Taels, ICT Manager at Plastiflex Group
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The medical device industry faces complex supply chain challenges that stem from regulatory shifts, fast moving technological advancements, global market dynamics, and evolving healthcare expectations. With so many moving components, the industry’s supply chains can fall short resulting in production delays, penalties, recalls and reputational damage, culminating in ‘costly unknowns’.
To remain competitive and meet these diverse operational hurdles, organizations must focus on product identification. By implementing cloud-based medical label design software, it strengthens traceability, authenticity, and makes connections across the supply chain.
Integrate artwork management and label production for medical devices, secondary packaging, and distribution with speed and accuracy
Manage regulations such as FDA 21 CFR Part 11, FDA Unique Device Identification (UDI), and the European Union’s Medical Device Regulations (EU MDR), reducing risks, errors, and fines
Ensure accurate label localization across languages and symbols, meeting evolving global requirements effortlessly
Support UDI requirements, recalls, ESG demands, and waste management
Provide industry-leading documentation, guidance, and support to aid the validation process
Integrate with PLM, MES, and ERP applications as well as any SAP landscape - safeguarding migration to SAP S/4HANA, and supporting supplier/customer connectivity
It’s all right there™
Centralize and standardize your labeling process in the cloud to design, manage, and print labels with greater control and consistency. Ensure accuracy and compliance across global operations while integrating seamlessly with your ERP, WMS, MES, and PLM systems. As your business grows, you can scale effortlessly with a flexible, cloud‑based labeling solution.
Learn more about Labeling with Loftware CloudTransform your packaging artwork process from concept to shelf with a streamlined, automated workflow that eliminates delays. Real‑time collaboration keeps internal teams and external partners aligned, while centralized content management ensures accuracy and consistency. You can also track budgets, manage costs, and maintain compliance - all within a single, unified system.
Discover Artwork Management with SmartflowConnect and govern product identity across your supply chain with a collaborative network that aligns suppliers, customers, and locations. Securely share approved standards, labels, data, and rules so every partner works from the latest version, ensuring compliance and operational efficiency. As your ecosystem expands, scale seamlessly with a connected network that keeps every partner in sync.
Unify product identity across your supply chain
Cross-platform integration
Data driven labeling for compliance
Automate translation management
Centralized control for traceability
Leverage business applications & digital technologies
Simplify validation/cloud assurance
Build efficiencies and enable accuracy with end-to-end solutions that share common approved content for labels and packaging - including information for use, UDI data, expiration dates, barcodes, ISO symbols, and images used throughout the product lifecycle.
Make the connection by integrating labels across printers, manufacturing environments, and software systems globally to eliminate bottlenecks, streamline operations and ensure consistent, accurate, and efficient labeling.
We were looking for a state-of-the-art, enterprise-wide labeling solution for all Siemens Healthineers to keep pace with market demands.
Mark Illgner
Senior Labeling Development Engineer
We were able to go from a 30-minute conversation with an auditor about how we can produce a label, to a couple of minutes to log into the system and provide the actual label image to the auditor.
Michael R. Kinnett
Product Labeling, Medical Products Division
We can now ensure global market access for our medical devices and tailor label content as required, leading to faster product approval and reduced regulatory delays.
Mark Illgner
Senior Labeling Development Engineer
Loftware’s Validation Acceleration Pack was a ‘lifesaver’. It gave us the main structure that we needed for external audit reasons to document the system correctly.
Patrick Taels
ICT Manager
Meeting regulatory labeling and product identification compliance on a global scale while addressing regional nuances around language and symbologies is challenging.
Medical device manufacturers, co-packers, and suppliers must comply to ensure device integrity, patient safety, market access, and availability worldwide.
Loftware’s solutions ensure ‘it’s all right there’ to meet requirements, checking accuracy at every stage of compliance for standards and regulations including:
Identify and track medical devices throughout their lifecycle to improve product safety and streamlining the healthcare supply chain.
Rules that governs the production and distribution of medical devices within the European Union
Label content and format standards for Canadian market
Labeling requirements under Good Manufacturing Practice
Labeling requirements for medical devices and pharma products
Country-specific labeling standards for China
Global guidelines for labeling and packaging
