Our cloud solutions are purpose designed to address the specific challenges of medical device labeling, including compliance with regional Unique Device Identification (UDI) systems. We enable traceability through the supply chain - from manufacturing, through distribution, and patient use.
UDI is a regulatory system used to uniquely identify and track medical devices.
Whether it’s the USA’s FDA UDI, Europe’s EU MDR, India’s CDSCO, or China’s NMPA, countries globally are adopting UDI. These systems assign a distinct identifier to each device, which improves patient safety, enhances the traceability, captures correct information, and streamlines regulatory processes.
Pour gérer ces réglementations en constante évolution à l'échelle mondiale, les entreprises de dispositifs médicaux doivent se concentrer sur une approche de l'étiquetage et de l'emballage basée dans le cloud, et automatiser la gestion des données afin de garantir l'exactitude de l'étiquetage et l'intégrité de l'UDI.
With complete data integrity, companies can mitigate risk, ensure quality, and reduce counterfeiting across the medical device product lifecycle.
Loftware’s medical device labeling software helps companies of all sizes manage labeling in a regulated environment by simplifying validation and compliance.
Best practice for managing UDI regulations is to source data from approved content, trusted ERPs, and other applications that generate serial numbers required for UDI
Be agile with constantly changing regional and international regulatory labeling requirements
Ensure auditability with eSignature and business intelligence that allows you to review, analyze and report on all activities to safely meet regulations
Whether using color thermal, inkjet printers, or pre-printed stock, our solutions ensure regulatory-compliant labels by populating pictograms and hazard elements, dynamically using business rules and transactional data
Manufacturers may have many locations, but that doesn’t mean it should be “every entity for itself.” Centralized labeling brings visibility and control – and the ability to demonstrate compliance
Spreadsheets, legacy systems, and general labeling software packages are not secure. Use an automated, validated solution that can easily accommodate new requirements and safeguard against future regulations
The Product Labeling team can support over 3,800 SKUs with only 75 label designs and 7000 image files. The team can easily swap format files and images based on customer needs, quickly adjusting languages, product brand name, size details, information, and instructions on the labels to comply with regional customer or regulatory requirements.
Michael R. Kinnett
Étiquetage des produits, division des produits médicaux
Loftware has been a great product for us. We have had great customer support with questions regarding UDI and GS1 last year.
Responsable informatique
Enterprise healthcare company
Nous pouvons désormais garantir l'accès au marché mondial pour nos dispositifs médicaux et adapter le contenu de l'étiquette en fonction des besoins, ce qui permet d'accélérer l'approbation des produits et de réduire les délais réglementaires.
Mark Illgner
Ingénieur sénior en développement d'étiquetage
Notre objectif était donc de mettre en œuvre un processus de gestion de l'étiquetage intégré garantissant l'exactitude des étiquettes et l'intégrité des données.
Patrick Taels
ICT Manager
