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Eurofins España >> Medical Device

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Two female scientists in a laboratory wearing safety goggles and lab coats, working with pipettes and medical devices. The image is related to medical device services, emphasizing precision and expertise in a clinical or research setting

Precisión. Competencia. Proximidad.

Ayudamos a las empresas en el desarrollo y la gestión durante todo el ciclo de vida de sus productos sanitarios a través de nuestra red mundial de expertos en reglamentación, más de 20 laboratorios y 2 centros de envasado estéril en Europa, Norteamérica y Asia Pacífico. Tanto grandes empresas como PYME se benefician de nuestros más de 40 años de experiencia y capacidades para preparar sus productos para el lanzamiento al mercado y las actividades de post comercialización a través de tres áreas de servicios independientes: consultoría, ensayos y envasado estéril.

Nuestra amplia experiencia en los procesos de comercialización, los requisitos normativos y las tendencias del sector garantiza la rápida realización de su proyecto con el máximo nivel de servicio y las tecnologías más avanzadas.

Nuestros servicios

Consultoría

Ensayos

Envasado estéril

Número de proyectos anuales

1710

Consultoría

23000

Biocompatibilidad

580

Envasado estéril

Medical Device Testing

Advanced solutions ensure the safety, efficacy, and quality compliance of your devices.

Maintain Sterile Barrier Integrity with Eurofins

Sterile Barrier Integrity Testing is critical throughout the course of distribution and storage for all terminally sterilised medical devices. Let Eurofins Medical Device Testing determine the most appropriate testing method based on your device and/or packaging configurations to ensure device integrity per ISO 11607, ASTM F1929 or ASTM F2096. Watch the video to learn more.

Medical Device Consulting

The partner you can trust to manage the lifecycle of your medical device.

Verify the Shelf Life of Your Device

Any medical device brought to market must have an expiration date, backed by shelf life testing. Eurofins Medical Device Testing’s shelf life and accelerated aging testing services ensure your device meets its intended use just as effectively after years of storage as the day it was manufactured. With more than 12.200 m3 of storage space, and a wide range of environmental chambers for predefined and custom conditions, our state-of-the-art labs support all aspects of your aging studies. Watch the video to learn more about our complete capabilities.

Eurofins Medical Device Sterile Packaging: Safe. Sterile. Packing.

From the raw compounds to the medical device, ready-for-sale – we ensure highest quality at utmost safety. 100% service from one source: That’s what inpac Medizintechnik has proven for 15 years. We’ll find your solution. Custom-made, fast, economical. Simply competent.

Your Global Package Testing Partner

Eurofins Medical Device Testing’s state-of-the-art Package Testing Lab is GMP, ISTA certified and ISO 17025 accredited to help evaluate every aspect of your packaging and labeling configurations. Our experts help perform functional testing, material testing, and accelerated and/or real time aging studies of primary and secondary packaging configurations to ensure your product will survive the rigors of global transit. Watch this video to learn more about our complete capabilities.

Eurofins Medical Device Service Sterile Packaging

We package your products! Innovative, sterile, legally valid – including the necessary steps for you towards MDR-Compliant Certification.

Ensure Your Device Survives Global Transport

No matter how or where your device is shipped, it is important to ensure your product will survive the rigors of global transit. Our state-of-the-art laboratory testing very precisely simulates various standard and custom distribution cycles per ISO 11607 and ASTM D4169, for the environmental conditions your packaging will encounter during transit. As you finalize your packaging designs, and prepare to conduct your validation work, our team of engineers is ready to work with you to ensure your product gets to its destination in the same condition it leaves your facility.

Nuestra experiencia

Nuestros expertos

Casos prácticos

Quiénes somos