Arazy Group Consultants LTD.

Arazy Group Consultantsは、いくつかの大陸にまたがる国際的なコンサルタント会社で、医療およびIVDデバイス企業が新しい市場に参入しようとする際の規制遵守および業務を支援します。 1995年に設立されたArazy Groupは、世界125カ国以上で事業を展開しています。 Arazy Groupは、初期の中堅企業、およびトップ100社の多国籍MedTech企業にサービスを提供してきました。

 

規制問題による公衆衛生管理の改善

20年に渡って運営している私たちは、機械学習の力、データ管理の効率、そしてプロフェッショナルネットワークの接続性を新しいテクノロジーサービスプラットフォームに結合する必要性を見てきました。そのため、2013年には、国際的な規制業務を合理化、簡素化、および迅速化するために設計された、クラウドベースの製品の統合スイートを発表しました。当社の製品とサービスは、1つのグローバルな規制管理システム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結び付けます。

 

2018年の終わりまでに、LICENSALE.COMは何百もの医療とIVDの製造業者が米国とEUを含む40の市場で3000以上の市場登録を処理することを可能にしました。 LICENSALE.COMは、世界規模で、先進医療製品へのより迅速で平等なアクセスと実践のための製品化までの時間を短縮することによって、著しい進歩を遂げることを可能にします。

「世界規模で、先進医療製品へのより迅速で平等なアクセスと実践のための市場投入期間を短縮します。」

– 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

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.

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

ARAB HEALTH 2019

Meet us at Arab Health, January 28- 31, 2019 in Dubai, UAE. 

Book a meeting with us to learn more about LICENSALE.COM.

MEDICAL JAPAN 2019

Meet us at Medical Japan, Febuary 20- 22, 2019 in Osaka, Japan.

Book a meeting with us to learn more about LICENSALE.COM.

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.

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

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.

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.”

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.”

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.”