Medical device manufacturers face an array of challenges in delivering products to domestic and international markets, from compliance to product recalls.
With risks to patient safety, regulatory review, and ultimately brand equity, organizations must ensure that labeling, documentation, and packaging processes comply with the current standards of each country utilizing their devices. It is also critical for these organizations to adopt systems and practices that enable them to react quickly to changing requirements.
For medical device manufacturers, labeling includes any type of packaging or product identification, the description of the product, its capabilities, and its intended use. This broad definition of labeling compounds the challenges to meet international regulatory compliance.
The variety of product identification standards in use today complicates harmonization efforts, with identification standards that include Unique Device Identification (UDI), Global Unique Device Identification Database (GUDID), Global Standards 1 (GS1), and European Union Medical Device Regulation (EU MDR), and other standards used in tracking products through the global supply chain. For medical device manufacturers, this can include contract manufacturers, private label and re-label partners, distribution points, and point of use healthcare providers.
Many companies in the medical manufacturing field merge and acquire other similar companies over several years, creating challenges in integrating disciplined labeling processes. Organizations that can create synergy in these environments with their labeling platforms are at a competitive advantage. One of the leading causes of product recalls is tied to inaccurate or non-compliant labels. Pragmatyxs provides compliance through the utilization of our PXSmartPrint, PXSmartLabel, and related validation consulting services.
The solution to these business challenges and requirements is a centralized and disciplined labeling approach; from the design of the label through to the printing of that label. Pragmatyxs can do this, with most 3rd party labeling software or our own proprietary product, PXSmartPrint, an integrated solution. This provides a labeling system that allows companies to automate the label language, the compliance format (CFR PART11 ), and the layout to automatically populate labels for any international destination.
With PXSmartPrint, labels can now be driven by any of the customer’s multiple databases using a standards-based solution and with a centrally located and controlled web-based enterprise-class label design and on-demand print solution. This solution eliminates dependence on a proprietary system and external translation services and allows companies to leverage their multiple databases, automatically achieve international label compliance, and drive compliance labeling.
When it comes to a trusted solution, Pragmatyxs can:
- Recommend software solutions that best integrate with your ERP system.
- Modify, if needed, the labeling software solution to accommodate the unique needs and demands of each business unit within a company for tracking and traceability within the ERP system.
- Set up reporting structures for compliance with the FDA and other agencies for accountability.
- Work closely with packaging, label designers, document management, manufacturing, and IT to ensure a cohesive relationship and workflow.
- Analyze partners, suppliers, international manufacturing, and distribution to set up a unified labeling compliance solution.
- Offer best practice advice based on lessons learned from other leading medical device manufacturers.