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LICENSALE.COM®是一个结合了先进数据管理,机器学习和AI的专家系统。 它消除了冗余并简化了当前产品上市前批准实践中的复杂流程。

标准注册周期 vs. LICENSALE.COM®

LICENSALE.COM®的专有技术将标准医疗设备注册周期从12步降低到5步。 在任何受监管的市场中批准销售产品,其中只有3个步骤需要医疗技术制造商采取行动。

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前所未有的能力

LICENSALE不仅简化了注册流程,还提供了比使用经销商或顾问更多的好处。 LICENSALE使您拥有控制全球注册策略的主动权,消除进入新市场或拥有许可证时对第三方的依赖。

 

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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

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.”

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.”

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.

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. “

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.”