Global UDI compliant labeling
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.
Key steps to compliance
Integrate with sources of truth
Best practice for managing UDI and other labeling regulations is to source data from approved content, trusted ERPs and other applications that generate serial numbers required for UDI.
Rapid response to regulatory labeling demands
Be agile with changing regional and international regulatory requirements for labeling, including those mandated by the FDA's UDI Systems
Accurate Reporting
Ensure auditability with eSignature and business intelligence that allows you to review, analyze and report on all activities so you can safely meet regulations
Enable data-driven labeling
It’s important to have dynamic labeling that enables users to manage a single template for a range of variations to support increasing complex requirements and speed up the validation process
Centralize your data
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.
Re-think legacy systems
Spreadsheets, legacy systems and even some labeling software packages are not secure. You need an automated, validated solution that can easily accommodate new requirements and safeguard against future regulations.
Keep pace with global UDI regulations
Whether it’s the USA’s FDA UDI, Europe’s EU MDR, India’s CDSCO, or China’s NMPA, countries globally are adopting UDI systems. UDI improves patient safety, enhances the traceability of medical devices, and streamlines regulatory processes.
To manage these evolving regulations globally, medical device organizations must focus on a cloud-based approach to labeling and packaging and automate data management to ensure accurate labeling and UDI integrity.
Data integrity mitigates risk, ensures quality, and positively impacts UDI across the medical device product lifecycle. Loftware’s labeling solutions help companies of all sizes manage labeling in a regulated environment by simplifying validation and compliance.
Get the latest developments in labeling in the medical device industry
White Paper
Navigating a smooth course through the Unique Device Identification journey
Unique Device Identification (UDI) systems are being implemented globally. To manage these evolving regulations,...
Report
Turning Roadblocks into Pathways to Success
Get the latest insights on how you can boost your labeling and packaging processes to optimize your time to market.
Case Study
Quest Medical reduces label turnaround time by 70%
Learn how Loftware Spectrum helped Quest Medical create new efficiencies and drive ROI including reducing the number of...
Blog
The importance of accurate labeling in medical devices: a personal and professional perspective
Warren Lesack, Senior Account Executive, Life Sciences at Loftware, shares his personal story about a life-changing...