Arazy Group Consultants LTD.

是一家跨越多个大洲的国际咨询公司,协助医疗和IVD设备公司在试图进入新市场时遵守法规和事务。 Arazy Group成立于1995年,业务遍及全球125个国家。 Arazy Group一直以来都在为早期的创业公司,中型公司和100强跨国公司医疗技术公司提供优质服务。

通过法规事务改善公共医疗保健

通过二十年的经营,我们已经看到将机器学习的力量,数据管理的效率以及专业网络的连接性结合到新的技术服务平台中的需求。 因此,在2013年,我们推出了一整套基于云的产品,旨在流程化,简化和加快国际法规事务。 我们的产品和服务通过一个全球法规管理系统LICENSALE.COM®来连接医疗设备制造商,监管机构和行业专家。

到2018年底,LICENSALE.COM使数百家医疗和IVD制造商在40个市场(包括美国和欧盟)完成了3000多个市场注册。 LICENSALE.COM使我们能够通过加快产品上市时间来取得重大进展,从而在全球范围内更快,更公平地获取先进医疗产品和实践。

“加快产品上市时间,以便在全球范围内更快,更公平地获取先进医疗产品和实践。”

– Benjamin Arazy

成立年份

与Arazy Group建立信任的公司

超过125个国家的医疗和IVD设备注册

行业和学术机会

Arazy Group 医疗技术启动计划
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

学生大使计划
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! 

招聘
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.

行业和学术机会

Arazy Group 医疗技术启动计划
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

学生大使计划
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! 

招聘
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.

网络研讨会

加入我们的网络研讨会,了解有关LICENSALE.COM®的更多信息,并在做出决定之前设置医疗和IVD注册,续订或许可转让的预算。

我们的“更快进入全球市场的高级医疗技术注册技巧”多语种网络研讨会每月会多次举办,以帮助回答您的问题。

我们同样提供个人演示,点击这里安排你的个人演示。

Exhibitions

MEDICAL JAPAN 2019

Thank you to those who met with us in Osaka and Tokyo. 

 

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.

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.”

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. “

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.”