SOLUTIONS > INDUSTRIES > MEDICAL DEVICE
Today’s medical device companies have the added pressure of complying with regulatory requirements like the FDA's Unique Device Identification (UDI) and the EU’s MDR systems, while keeping operations running smoothly. That's why more manufacturers are reevaluating their medical device barcode labeling and packaging processes in order to adapt more easily to emerging regulatory requirements and sustain compliance, while keeping up with growing market demands.
Loftware’s combined platform–whether for labeling, artwork management or both – enables customers to uniquely meet regulatory mandates, mitigate risk, reduce complexity, ensure traceability, improve time to market and optimize costs as they meet customer-specific, brand, regional and regulatory requirements with unprecedented speed and agility.
Spreadsheets, legacy systems and even some labeling software packages are not secure. You need an automated, validated medical device labeling software that can easily accommodate new requirements and safeguard against future regulations.
Your business 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 and meet corporate standards.
Best practice for managing FDA's UDI, EU MDR and other labeling regulations is to source data from approved content management systems, trusted ERPs and other applications that generate serial numbers required for regulations.
Business users should be able to create and manage medical barcode labels and configure business rules without calling on IT. This allows them to quickly respond to any pressing regulations.
You need a labeling solution that provides full auditing and reporting capabilities, with business intelligence to monitor and track all labeling activity and eSignature capabilities - to safely meet regulations.
Dynamic, data-driven labeling enables users to manage a single template for a range of labeling variations to support increasing complex requirements and speed up the validation process.
No wonder many of leading medical device companies rely on Loftware’s Solutions for Life Sciences. Loftware Spectrum for Medical Device and Loftware Smartflow give you the power and flexibility to meet changing customer and regulatory requirements, improve response times and reduce overall costs - all while driving greater efficiencies across your extended supply chain. Whether creating labels or packaging artwork, administering clinical trial labels or managing Instructions for Use (IFU/eIFU), you can comply with customer and regulatory demands to keep product moving quickly —even across international boundaries.
Download the following report to learn how medical device manufacturers are using Enterprise Labeling to meet the evolving demands of the supply chain when disruptions occur.
Download →With the next milestone for Medical Device Regulation approaching, companies need to reassess label and packaging artwork processes to ensure compliance.
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