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.
Če bodo proizvajalci medicinskih pripomočkov želeli globalno obvladovati te spreminjajoče se predpise, se bodo morali osredotočati na pristop k označevanju in pakiranju v oblaku ter avtomatizirati upravljanje podatkov, da zagotovijo natančno označevanje in integriteto EIN.
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
Označevanje izdelkov, oddelek za medicinske pripomočke
Loftware has been a great product for us. We have had great customer support with questions regarding UDI and GS1 last year.
IT Manager
Enterprise healthcare company
Zdaj lahko zagotovimo dostopnost svojih medicinskih pripomočkov na globalnih trgih in po potrebi prilagajamo vsebino etiket, kar vodi do hitrejše odobritve izdelkov in manjših zamud pri regulativnih postopkih.
Mark Illgner
Vodilni inženir za razvoj označevanja
Our goal was to implement an integrated label management process that guaranteed accurate labels and data integrity.
Patrick Taels
ICT Manager
