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)
成立年份
与Arazy Group建立信任的公司
超过140国家的医疗和IVD设备注册
Seminar & Webinars
Thursday at 11:00 AM PDT
Wednesday at 11:00 AM CEST
REGtalks France: Euraisa, Latin America and Southeast Asia
REGtalks Turkey: USA, Eurasia and Latin America
Events & Exhibitions
Meet our team in Seoul, Korea
Meet our team in Tokyo, Japan
Unable to Meet Us in Person?
Schedule your online personal demonstration now!
Industry Publications
Read the lastest news publications about Arazy Group Consultants
Industry and Academic Opportunities
Arazy Group 医疗技术启动计划
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.
- A Regulatory Strategic Report for your product’s US and EU pre market clearance. (Class I/II/III)
- An Established ISO13485/21 CFR 820 Quality Management System.
- 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
招聘
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!
Industry and Academic Opportunities
Arazy Group 医疗技术启动计划
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:
- A Regulatory Strategic Report for your product’s US and EU pre market clearance. (Class I/II/III)
- An Established ISO13485/21 CFR 820 Quality Management System.
- 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
招聘
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.
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.
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.”
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.”
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