Dispositivos médicos

    Redefining medical device labeling to meet regulations, control costs, and scale operations in an evolving landscape

    100 %

    W.L. Gore achieves 100% label accuracy

    70 %

    Quest Medical reduce el tiempo de respuesta de las etiquetas en un 70 %

    Nuestro objetivo era implementar un proceso integrado de administración de etiquetas que garantizara precisión en las etiquetas e integridad de los datos.

    Patrick Taels, ICT Manager at Plastiflex Group

    etiquetado support for a healthy supply chain

    The medical device industry faces complex supply chain challenges that stem from regulatory shifts, fast moving technological advancements, global market dynamics, and evolving healthcare expectations.

     

    To remain competitive and meet these diverse operational hurdles, organizations must focus on product identification. By implementing cloud-based medical label design software, it strengthens traceability, authenticity, and increases connectivity across the supply chain.

    Streamline labeling & production

    Integrate artwork management and label production for medical devices, secondary packaging, and distribution with speed and accuracy

    Enable global compliance

    Manage regulations such as FDA 21 CFR Part 11, FDA Unique Device Identification (UDI), and the European Union’s Medical Device Regulations (EU MDR), reducing risks, errors, and fines

    Support global & regional labeling

    Ensure accurate label localization across languages and symbols, meeting evolving global requirements effortlessly

    Track & trace products

    Support UDI requirements, recalls, ECG demands, and waste management

    Be validation ready

    Provide industry-leading documentation, guidance, and support to aid the validation process

    Boost supply chain collaboration

    Integrate with PLM, MES, and ERP applications as well as any SAP landscape - safeguarding migration to SAP S/4HANA, and supporting supplier/customer connectivity

    Nuestros productos

    The right choice
    for your business

    Dispositivos médicosLoftware Cloud Compliance

    Simplifica tu proceso de cumplimiento normativo con la solución de etiquetado en la nube lista para validar de Loftware. Esta solución, diseñada para fabricantes de productos sanitarios, reduce el riesgo regulatorio y acorta los plazos de comercialización en empresas de todos los tamaños.

    Garantiza un cumplimiento normativo escalable
    Administración de material gráficoLoftware Smartflow

    Optimiza la gestión de tu material gráfico para embalajes con flujos de trabajo automatizados, aprobaciones integradas y colaboración en tiempo real. Acorta el plazo de comercialización y garantiza el cumplimiento normativo con Loftware Smartflow.

    Conoce Smartflow en acción

    Implanted solutions for your labeling ailments

    Staying ahead of compliance challenges

    Meeting regulatory labeling and identification compliance on a global scale while addressing regional nuances around language and symbologies is challenging.

     

    Medical device manufacturers, co-packers, and suppliers must comply to ensure device integrity, patient safety, market access, and availability worldwide.

     

    Loftware’s solutions ensure you meet requirements, ensuring accuracy at every stage of compliance for standards and regulations including:

    FDA 21 CFR Parte 11

    Electronic records and signatures for compliance in labeling

    UDI

    Identify and track medical devices throughout their lifecycle to improve product safety and streamlining the healthcare supply chain.

    MDR de la UE

    Rules that governs the production and distribution of medical devices within the European Union

    Health Canada Labeling Requirements

    Label content and format standards for Canadian market

    GMP Guidelines

    Labeling requirements under Good Manufacturing Practice

    ISO 13485

    Labeling requirements for medical devices and pharma products

    China FDA (CFDA) Regulations

    Country-specific labeling standards for China

    WHO Good Manufacturing Practices (GMP)

    Global guidelines for labeling and packaging

    Additional resources