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LICENSALE.COM® es un sistema experto que combina funciones avanzadas de gestión de datos, aprendizaje de máquinas y AI. Elimina la redundancia y simplifica los procesos complejos que se encuentra en la práctica actual de aprobación del producto previa a la comercialización.

Ciclo de vida de registro estándar vs. LICENSALE.COM®

La tecnología patentada LICENSALE.COM® reduce el ciclo de vida estándar de registro de dispositivos médicos de 12 a 5 pasos. Sólo 3 pasos verdaderamente requieren acción del fabricante de tecnología médica para lograr que el producto sea aprobado para su venta en cualquier mercado regulado.

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No sólo LICENSALE simplificar el proceso de registro, sino que también proporciona beneficios adicionales sobre el uso de distribuidores o consultores. LICENSALE le permite tomar el control de su estrategia global de registro, eliminando la necesidad de depender de terceros para llegar a nuevos mercados o a poseer una licencia.

¡Conviértase en un experto en registro de dispositivos médicos a nivel mundial!

 

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Hanin Medical

“We were very excited to receive our 510k clearance for the SAAD patient monitor months earlier than anticipated with Arazy Group. Arazy Group went above and beyond for this project and we are very happy with the result, which marks the first registration project of its kind in the USA and EU.» – Rudolf Holzhausen, PhD.

Elekta, United Kingdom

«Arazy Group’s approach to regulatory affairs and goals with regards to emerging markets are wholly in line with Elekta’s long-term goals. We are able to approach new opportunities with confidence that we can find a solution to the challenge.”

SPD Swiss Precision Diagnostics GmbH

«Advantages of working with Arazy Group include their expert knowledge of regulatory processes in many markets throughout the world and that they offer a dedicated Arazy Group client manager, acting as a single point of contact with whom we can discuss the progress of ongoing projects and raise specific questions or concerns.»

OraSure Technologies, Inc.

«We have been using LICENSALE.COM for obtaining and maintaining our device licenses in global markets. This system is a great tool for registering products in all jurisdictions including those that do not have defined regulatory pathway. «

Visionsense Ltd.

«Arazy Group has guided us with quality management and registration for over 10 years, obtaining licenses for our devices in the USA, EU, and Canada, with more projects underway. The seamless relationship between our teams has enabled us to maintain our quality management system at a high level and our ongoing cooperation is very fruitful and constructive.» – Azi Ben-Yishai

Luminex Corporation

“Arazy Group has been instrumental in the commercialization of our IVD medical devices. Their expertise has allowed our company to successfully obtain product approval and expand access to our technology in three new markets over the past three years, with three additional markets underway.”