Medical Device

Sustain Compliance, Improve Operations.

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. 

Enterprise Labeling for Medical Device 

Loftware Spectrum for Medical Device enables companies throughout the Medical Device supply chain to transform labeling into a high-value, strategic element of the overall manufacturing and distribution process. By tightly integrating medical device labeling with business processes you already use, you can:

  • Automate and centralize labeling to improve accuracy and eliminate complex, error-prone data replication
  • Respect and leverage “validated sources of record” to comply with regulatory, customer and CMO requirements
  • Easily build and securely share templates that comply with UDI, 21 CFR Part 11 ERES and other regulations  
  • Reduce label template maintenance with an integrated and automated solution
  • Quickly configure and update medical device labels to meet evolving needs, expand into new markets
  • Save time and reduce cost of implementing a validated enterprise labeling solution
  • Extend labeling to distributors, suppliers, 3PLs to eliminate relabeling—save millions in inventory costs
  • Leverage standardized enterprise-wide labeling and GS1 standards to improve tracking and tracing of  medical devices

Artwork Management for Medical Device

The right Artwork Management Solution lets Medical Device companies take control of product packaging processes to easily meet regulatory requirements and manage high volumes of packaging labels and label changes. By implementing an automated Artwork Management process to manage packaging artwork throughout the product lifecycle, you can:

  • Integrate with business applications including ERPs and PLMs that house data you already use to leverage existing processes and “sources of truth” to improve efficiency and accuracy and comply with customer, regional and regulatory requirements including FDA UDI, 21 CFR Part 11 and EU MDR and IVDR
  • Ensure control and compliance with robust and reliable validation services that can be implemented quickly and efficiently to enable full version control, audit trail and traceability reports
  • Centralize content and integrate asset management to easily control unstructured data and versions including pack copy, warnings and translations
  • Automate and track all of your workflows to keep a permanent record of all approval points, status, dates and users associated with the critical path
  • Ensure security and control to reduce errors, minimize risk and limit recalls by managing business processes and content with role-based access for stakeholders and supply chain partners
  • Address multi-lingual copy requirements with phrase/translation management capabilities offering library of common phrases, in any language, to ensure product has appropriate and accurate labeling for regions across an international landscape
  • Drive continuous improvements with insight into packaging artwork workflows with business intelligence and KPI reporting

No wonder many of leading Medical Device companies rely on Loftware Solutions. 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. You can comply with customer and regulatory demands to keep product moving quickly —even across international boundaries.

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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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Report: The Digital Transformation of Artwork Management

As packaging artwork becomes more important to the product lifecycle and to the new product development process, it is more important than ever to manage the process effectively.

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