登録業務の再考

LICENSALE.COM®は、高度なデータ管理、機械学習、そしてAIを組み合わせたエキスパートシステムです。 それは冗長性を排除し、現在の製品の市販前承認慣行に見られる複雑なプロセスを単純化します。

標準の医療機器登録ライフサイクルvs LICENSALE.COM®

LICENSALE.COMの独自技術は、標準医療機器登録ライフサイクルを12から5ステップに短縮します。本当に規制された市場で販売のために承認された製品を得るために医療技術メーカーが行うことはほんの3つのステップだけです。

LICENSALE.COM®

これまでにない機能

LICENSALEは登録プロセスを簡素化するだけでなく、販売代理店またはコンサルタントを使用する以上の利益を提供します。 LICENSALEを使用すると、グローバル登録戦略を積極的に管理し、新しい市場へのアクセスやライセンスの取得に第三者機関に頼る必要がなくなります。

グローバル医療機器のエキスパートになる

の個人用デモをリクエストする
*Same day demos are not available

お問い合わせを送信


* 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.”

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.”

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.

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.”

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. “