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Products overview

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.

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Key steps to compliance

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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.

Regulations

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

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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

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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

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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.

business-processes

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. 

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Stay UDI-compliant with Loftware

We enable authentic, compliant, and traceable products through the connected supply chain. We are the most comprehensive labeling and artwork management solution in the industry. Loftware offers validation-ready solutions for cloud environments so that you can keep pace with the latest regulations, and quickly deploy a compliant labeling process globally.