Sustain Compliance, Improve Performance

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 and more manufacturers are reevaluating their labeling and packaging processes in order to adapt more easily to emerging regulatory requirements and sustain compliance, while keeping up with growing market demands.

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Best Practices

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.

Re-think Legacy Systems

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.

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 and meet corporate standards.

Integrate Sources of Truth

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.

Enable Label Changes

Business users should be able to create and manage medical labels and configure business rules without calling on IT. This allows them to quickly respond to any pressing regulations.

Ensure Security/Auditability

You need a 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.

Enable Data-Driven Labeling

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 Solutions. Loftware Spectrum for Medical Device labels and Loftware Smartflow give you the power and flexibility to meet changing customer and regulatory requirements, improve response times and reduce costs - all while driving greater efficiencies across your extended supply chain and helping you easily support new languages, new market requirements and quickly expand usage across international boundaries so you can be ready for future regulations. You can comply with customer and regulatory demands to keep product moving quickly.


Related Resources


Regulatory Labeling Guide: 6 Best Practices to Sustain Compliance

While different industries have different regulations, they all have common labeling challenges. Check out these best practices that will help you meet compliance while driving supply chain excellence.

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White Paper: Is Your Labeling and Artwork Ready?

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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S&P 500 Regulatory Compliance