La calidad está en nuestro ADN. Reconocemos que la vida y el bienestar de los pacientes de todo el mundo dependen de la llegada segura de los productos sanitarios críticos. Nuestro compromiso es mejorar continuamente la excelencia de nuestra calidad y creamos un potente sistema de administración de la calidad que nos ayuda a hacerlo todos los días.
Contactar a Nuestros ExpertosLe ayudamos a moverse por las normativas de cumplimiento internacionales en casa y a través de las fronteras internacionales. We have relationships with more than 80 regulatory agencies, and our facilities maintain local regulatory licenses in addition to ISO 13485 and ISO 9001 certifications.
La calidad es un elemento esencial de cualquier empresa sanitaria o de ciencias biológicas. Hemos desarrollado procesos coherentes y reproducibles que aplicamos globalmente para proporcionar efectividad, agilidad y cumplimiento normativo.
Our eQMS offers a single, globally integrated eQMS platform enabling advanced data-driven trend analysis reports that give you the opportunity to continually optimize and improve performance over time.
Respaldamos los esfuerzos de nuestros clientes para entregar productos seguros y eficaces al mercado, y utilizamos la metodología de validación actual para habilitar las instalaciones y sistemas críticos con el fin de asegurar que estén al día con las normas y mejores prácticas de la industria.
We have dedicated and independent Quality Assurance and Regulatory Affairs experts around the world with the specialized education, qualifications, and experience required for managing healthcare compliance in the countries and regions we serve.
Protect your global supply chain with a highly configurable quality management system designed to maintain the safety and efficacy of regulated healthcare products.
Programar auditorías
Programar inspecciones de procesos del centro
Revisar hallazgos
Revisar y aprobar respuestas
Aplicar puntuación
Registrar CAPA
Capturar acciones preventivas
Assess risk and impact breadth Track action plans Verify effectiveness
Evaluar el riesgo
Evaluar el impacto
Desarrollar planes de acción
Obtain approvals
Record non-conformances
Administrar acciones/retiros del mercado
Revisar investigaciones
Track action plans Identify trends
Administrar documentos controlados
Revisar y aprobar documentos
Aprobar variaciones adecuadas
Asignar entrenamiento
Evaluar la eficacia del entrenamiento
Monitorear el estado del entrenamiento
Identificar tendencias
Our approach to quality management is simple, we hold our systems, processes and procedures to the highest standard to ensure the safe arrival of healthcare products around the world.
We use our electronic QMS, and it helps protect your global supply chain with a highly configurable design to maintain the safety and efficacy of regulated healthcare products.
Sí. Complying with ever-changing requirements continues to be a top concern for healthcare. Since we operate in over 220 countries, our logistics teams are made up of experts with strong local relationships and we can provide services to help you manage your overseas business.
At our Package Testing Lab, we can test the sensitivity of packaging and the effects of extreme temperatures and humidity, so we know how packaging will perform in various conditions and adjust packaging strategy accordingly.
Our specialized air and ocean freight containers help keep your products within specified temperature ranges throughout the transportation cycle.
And with our global footprint of more than 70 facilities housing a full range of temperature-controlled environments, you can trust your products are in good hands.
Our facilities maintain local regulatory licenses in addition to ISO 13485 and ISO 9001 certifications, across a global network of more than 17.2 million square feet (1.5 million square meters) of warehouse space.