ARAZY GROUP CONSULTANTS

Inventor of Global Medtech

Registration Technology

With the launch of LICENSALE® – Global Medtech Registration System in 2013, Arazy Group took the lead on the provision of advanced registration and license management technology solutions, designed specifically for the medical and IVD device industry. 

Staying true to its company mission to make the best medical devices and medical practice available to patient and physicians around the world, LICENSALE® delivered thousands of new products registrations, amendments, renewals, and transfers of licenses over the past seven years. 

Leveraging on their experience and the latest advancement in software, database management, machine learning and A.I., Arazy Group developed the next generation in Medtech registration and license management software- LICENSALE® 2.0, REGISLATE® and the EUDAMEDtech© system.

“These are the days of change and transformation. I encourage everyone involved in bringing Medtech products to market implement the best practices to ensure their products are equally available for everyone in the most efficient way.”

– Benjamin Arazy, CEO (2020)

設立年

企業はArazy Groupを信頼しています

140カ国以上での医療機器およびIVDデバイスの登録

Seminar & Webinars

Webinar: How to Manage Global Medtech Approval Processes from Home

Thursday at 11:00 AM PDT

Wednesday at 11:00 AM CEST

This webinar is also available in the following languages:

Events & Exhibitions

Meet the Arazy Group team at the following exhibitions this year.
LA RENTRÉE DU DM

BESANÇON, France

September 29th + 30th, 2020

MEDICAL JAPAN

TOKYO, Japan

October 14th – 16th, 2020

Unable to Meet Us in Person?

Schedule your online personal demonstration now!

Industry and Academic Opportunities

Arazy Group MedTechスタートアップ構想

The Arazy Group MedTech Start-Up Initiative is a program that helps young MedTech start-up companies achieve US- FDA, CE Mark and ISO13485 certification at a significantly lower cost. The objective of this initiative is to significantly increase the availability of advanced solutions and medical device technology to physicians and their patients around the world.

Bring Your Start-Up to Success

If you are a start-up company, three to twenty-four months old and managing a budget of less than $500,000 US annually, please schedule your meeting to see if your company is eligible for any of the following products, sponsored by LICENSALE.

  1.  A Regulatory Strategic Report for your product’s US and EU pre market clearance. (Class I/II/III)
  2. An Established ISO13485/21 CFR 820 Quality Management System.
  3. Your product’s CE Mark:

a) EU – Class I/II Technical File

b) EU – Authorized Representative service

4. IV) Your product’s US – FDA clearance for a Class I/II product:

a) USA – Medical Device Registration | 510(k)

b) The USA – Regulatory Designated Agent

キャリア

Join Our Team!

Arazy Group provides a flexible and inclusive work environment. While we have five international offices, and a presence in more than 65 countries around the world, many of our employees and contractors work remotely according to their schedule and location. As such, our team members have a strong tendency to lead as dedicated, self-motivated individuals who believe in our mission and want to take part in it.

We are always looking for responsible, skilled, and passionate people for our departments, including sales, marketing, business development, regulatory intelligence and compliance, IT, finance, and human resources.

If you would like to inquire about open positions or apply for a posted position, send your cover letter and CV to [email protected] with the subject line “Arazy Group Career Opportunities”.

Qualified regulatory and technical experts are eligible to join the WORKNET™ global expert network.

 

Click here for current job openings!

Industry and Academic Opportunities

Arazy Group MedTechスタートアップ構想
The Arazy Group MedTech Start-Up Initiative is a program that helps young MedTech start-up companies achieve US- FDA, CE Mark and ISO13485 certification at a significantly lower cost. The objective of this initiative is to significantly increase the availability of advanced solutions and medical device technology to physicians and their patients around the world.

Bring Your Start-Up to Success

If you are a start-up company, three to twenty-four months old and managing a budget of less than $500,000 US annually, please complete our application form to see if your company is eligible for any of the following products, sponsored by LICENSALE.COM:

  1.  A Regulatory Strategic Report for your product’s US and EU pre market clearance. (Class I/II/III)
  2. An Established ISO13485/21 CFR 820 Quality Management System.
  3. Your product’s CE Mark:

a) EU – Class I/II Technical File

b) EU – Authorized Representative service

 

4. IV) Your product’s US – FDA clearance for a Class I/II product

   a) USA – Medical Device Registration | 510(k)

    b) The USA – Regulatory Designated Agent

キャリア
Join Our Team!

Arazy Group provides a flexible and inclusive work environment. While we have five international offices, and a presence in more than 65 countries around the world, many of our employees and contractors work remotely according to their schedule and location. As such, our team members have a strong tendency to lead as dedicated, self-motivated individuals who believe in our mission and want to take part in it.

We are always looking for responsible, skilled, and passionate people for our departments, including sales, marketing, business development, regulatory intelligence and compliance, IT, finance, and human resources.

If you would like to inquire about open positions or apply for a posted position, send your cover letter and CV to [email protected] with the subject line “Arazy Group Career Opportunities”.

Qualified regulatory and technical experts are eligible to join the WORKNET™ global expert network.

Arazy Group  – One World Process

Inquiry Form


* 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.

OraSure Technologies社

「我が社はこれまでずっとグローバルマーケットにおける当社の医療機器のライセンスの取得と維持管理をLICENSALE.COMを利用して行っています。このシステムは薬事規制が整備されていない国も含め,あらゆる国において製品の薬事登録を行ううえでとても優れたツールです。」

SPD (Swiss Precision Diagnostics) 社

Licensale Client Swiss Precision Diagnostics' logo

「Arazy Groupを利用するメリットは世界中の多くの国の薬事申請登録プロセスに関する専門知識を備えていることであり、また、Arazy Groupは専任のクライアントマネジャーを割り当ててくれることです。そのクライアントマネジャーが連絡窓口となりプロジェクトの進捗状況や質問や懸念について話し合うことができます。」

Visionsense社

「Arazy GroupはUSA、EUおよびカナダにおいて当社の医療機器のライセンスを取得し、品質管理と薬事登録に関して当社をサポートしてくれています。現在、さらに多くのプロジェクトが進行中です。両社のチームの切れ目のない関係により高いレベルで品質管理システムを維持することができています。Arazy Groupと我が社の継続する協力体制は大きく実を結んでいるとともに建設的です。」‐アジ・ベン・イシャイ

Hanin Medical社

LICENSALE Client Hanin Medical Center's Logo

Arazy Groupの予想よりも数か月早くSAAD患者モニターの510kクリアランスを受け取ったことに非常に興奮しました。 Arazy Groupはこのプロジェクトを上回っており、米国とEUでこの種の最初の登録プロジェクトとなった結果に非常に満足しています。」-ルドルフホルツハウゼン、博士。

Elekta社(英国)

LICENSALE Client Elekta's Logo

「Arazy Groupの新興市場に関する薬事と目標に対するアプローチはElektaの長期目標とすべて一致しています。課題に対するソルーションを見つけることができるという確信を持って新たな機会に臨むことができています。」

Luminex社

「Arazy Groupは当社のIVD機器を商品化するうえでサポートしてくれています。その専門知識のおかげで、当社はこの3年間で3つの新たな市場における製品の薬事承認取得に成功し、当社のテクノロジーの市場拡大を上手く行えました。現在、さらに3つの市場に申請しているところです。」