Arazy Groupコンサルタント

Arazy Group Consultantsは世界各国で展開するコンサルタント会社です。医療機器およびIVDデバイスの製造業者が新しい市場へ進出する際に必要となる規制関連業務を支援しております。Arazy Groupは1995年に設立され、現在世界125カ国以上で事業を展開しています。 Arazy Groupは創業間もない企業から中堅企業、世界トップ100社に入るような大企業までの広範囲に渡り、世界中の医療機器会社に選ばれてきました。

規制関連業務を介して人々の健康に貢献

20年に渡る運営の中で、機械学習の能力、データ管理の効率性、そしてプロの専門家による検閲の全てを結集させた新しいプラットフォームの必要性を見いだしてきました。そしてついに、2013年に海外の規制業務を合理化、簡素化、迅速化することを可能にしたクラウドベース型ソフトウェアを発表致しました。当社の製品とサービスは、グローバル医療機器登録システムLICENSALE.COM®を通じて医療機器製造業者、規制当局、および業界の専門家を一つに繋ぎます。2018年末までで、LICENSALE.COMは数百もの医療機器・IVDデバイス製造業者が米国とEUを含む40の市場で3000以上の医療機器登録を完了してきました。 LICENSALE.COMが製品化までの時間を短縮することによって、世界はより多くの人がより早く先進医療に辿り着けるという飛躍的な進歩を遂げております。

“Accelerate time-to-market for faster and equal public access to advanced medical products and practice, on a global scale.”

– Benjamin Arazy

設立年

企業はArazy Groupを信頼しています

125カ国以上での医療機器およびIVDデバイスの登録

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

学生アンバサダープログラム

Looking to get ahead in the MedTech industry? The LICENSALE University Outreach Program is here to help you advance, closing the gap between university and industry. Gain insight into the most advanced technology available to you in MedTech registration.

This is a great opportunity for students to:

  • Gain valuable volunteer experience for resume building
  • Make connections in the industry for future growth
  • Improve upon public speaking and leadership skills
  • Raise awareness of new regulatory affairs technology to help more patients, worldwide

Please submit an inquiry if you are interested! 

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 careers@arazygroup.com 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!

産業と学術の機会

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

学生アンバサダープログラム

Looking to get ahead in the MedTech industry? The LICENSALE University Outreach Program is here to help you advance, closing the gap between university and industry. Gain insight into the most advanced technology available to you in MedTech registration.

This is a great opportunity for students to:

  • Gain valuable volunteer experience for resume building
  • Make connections in the industry for future growth
  • Improve upon public speaking and leadership skills
  • Raise awareness of new regulatory affairs technology to help more patients, worldwide

Please submit an inquiry if you are interested! 

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 careers@arazygroup.com with the subject line “Arazy Group Career Opportunities”.

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

Webinars

Join our webinar to learn more about LICENSALE.COM®  and to set up a budget for medical and IVD registrations, renewals or license transfers before you make a decision.

Our Advanced Medtech Registration Techniques for Faster Global Access webinar is hosted several times a month in multiple languages to help answer your questions.

Personal demonstrations are also available, to schedule yours click here.

Exhibitions

RAPS REGULATORY CONVERGENCE

Meet us in Philadelphia this year and join us afterwards at the 2019 MedTech Regulatory Awards.

DATE: September 21st to 24th, 2019 

Events

MedTech Regulatory Awards

Arazy Group is proud to have created and hosted the MedTech Regulatory Awards; an event to celebrate and recognize regulatory affairs professionals in the medical and IVD device industry for their efforts to improve global, public health. All proceeds from this event go to the Arazy Group Start-Up Initiative.

The 2018 MedTech Regulatory Awards took place in beautiful Vancouver, British Columbia. 

Nominations for the 2019 MedTech Regulatory Awards will open in February 2019. 

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.

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. “

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.”

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.”