LICENSALE.COM®

全球医疗技术注册系统

LICENSALE让您可以全面控制您的法规事务,并在超过125个国家和地区获得医疗和IVD设备认证。 立即和LICENSALE一起成为全球医疗器械注册专家!

为什么选择 LICENSALE.COM

LICENSALE.COM®可在任何市场中分析合规性数据并执行机器学习,来管理医疗和IVD设备注册流程。 它消除了多余无用的信息,优化了效率,并将人类专业知识集中在真正需要的地方。

125+

个国家和地区

提早4个月

的上市时间

50%

花费降低

LICENSALE.COM如何运作?

LICENSALE.COM®的专有技术允许您采用标准的医疗设备注册周期(该周期为12个步骤),并将其减少到5个步骤。 Licensale使用以前注册的知识和数据,来最大限度地减少未来注册所需的过程。 您使用Licensale的次数越多,您的市场审批流程就越有效率和性价比。

更新

使用LICENSALE更新产品批准历史记录和合规性文档。

完成

您的注册申请将通过LICENSALE在全球超过125个国家和地区的授权代表和许可证持有人办事处提交给监管机构。 您是许可证的所有者!

检查

多位专家将检查您的文档是否符合每个市场的当地要求。 您将被告知任何信息缺失需要补充或进行更改。

学习

了解您在其他国家/地区的特定医疗设备合规性要求,以及每个市场的市场准入就绪指数(MARI%™)得分。

匹配

将您现有的合规性数据与您所在国家/地区的当地注册要求相匹配。 了解何时完成医疗或IVD设备的批准,续订,转让或修改。

更新

使用LICENSALE更新产品批准历史记录和合规性文档。

学习

了解您在其他国家/地区的特定医疗设备合规性要求,以及每个市场的市场准入就绪指数(MARI%™)得分。

匹配

将您现有的合规性数据与您所在国家/地区的当地注册要求相匹配。 了解何时完成医疗或IVD设备的批准,续订,转让或修改。

检查

多位专家将检查您的文档是否符合每个市场的当地要求。 您将被告知任何信息缺失需要补充或进行更改。

完成

您的注册申请将通过LICENSALE在全球超过125个国家和地区的授权代表和许可证持有人办事处提交给监管机构。 您是许可证的所有者!

成为全球医疗器械注册专家!
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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. “

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.”

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.”

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.”

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.