Re-Think Registration
LICENSALE.COM® is an expert system that combines advanced data management, machine learning and AI. It eliminates redundancy and simplifies complex processes found in the current product pre-market approval practice.
Standard Registration Life Cycle vs. LICENSALE.COM®
LICENSALE.COM®’s proprietary technology reduces the standard medical device registration life cycle from 12 to 5 steps. Only 3 steps truly require action from the medtech manufacturer to get the product approved for sale in any regulated market.
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Unprecedented Capabilities
Not only does LICENSALE simplify the registration process, it provides additional benefits over using distributors or consultants. LICENSALE allows you to take active control of your global registration strategy, erasing the need to rely on third parties to reach new markets or to own a license.
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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.”
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. “
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.
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