LICENSALE.COM

®

 

Global Medtech Registration System

LICENSALE lets you take full-control of your regulatory affairs and gain medical and IVD device approvals in over 125 countries. Become an expert in global medical device registration with LICENSALE, today!

Why LICENSALE.COM

®

LICENSALE.COM® analyzes compliance data and implements machine learning to manage the medical and IVD device registration process, in any market. It eliminates redundancy, optimizes efficiency and focuses the human expertise where it is really needed.

125+

Countries worldwide

4 Months

Faster time to market

50%

Lower cost

How Does LICENSALE.COM® Work?

LICENSALE.COM®‘s proprietary technology allows you to take the standard medical device registration life-cycle, which is 12 steps long and reduce it to 5 steps. Licensale uses knowledge and data from previous registrations to minimize the process required for future registrations. The more you use Licensale, the more efficient and cost effective your market approval processes will become.

Complete

Your registration application is submitted to the regulatory agency via LICENSALE’s Authorized Representative and License Holder offices in 125+ countries around the world. You are the owner of the license!

Check

Multiple experts will check your documents for compliance with local requirements for each market. You will be informed of any missing information or changes that need to take place.

Update

Update your product approval history and compliance documents with LICENSALE.

Learn

Learn your specific medical device compliance requirements in other countries and what their Market Access Readiness Index (MARI%™) scores are for each market.

Match

Match your existing compliance data with local registration requirements in your country of interest. Find out when your medical or IVD device approval, renewal, transfer or amendment will be completed.

Update

Update your product approval history and compliance documents with LICENSALE.

Learn

Learn your specific medical device compliance requirements in other countries and what their Market Access Readiness Index (MARI%™) scores are for each market.

Match

Match your existing compliance data with local registration requirements in your country of interest. Find out when your medical or IVD device approval, renewal, transfer or amendment will be completed.

Check

Multiple experts will check your documents for compliance with local requirements for each market. You will be informed of any missing information or changes that need to take place.

Complete

Your registration application is submitted to the regulatory agency via LICENSALE’s Authorized Representative and License Holder offices in 125+ countries around the world. You are the owner of the license!

Become an Expert in Global Medical Device Registration!

Request a personal demo of

LICENSALE.COM®

*Same day demos are not available

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* Note: If you use your general ISP e-mail address, such as gmail, yahoo etc. your LinkedIn profile address is required to process your request.

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.”

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. “

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.”