Arazy Group Consultants LTD.

Arazy Group Consultants is an international consultancy spanning several continents, assisting medical and IVD device companies with regulatory compliance and affairs as they try to enter new markets. Founded in 1995, Arazy Group operates in over 125 countries around the world. Arazy Group has been serving early start-up, medium-sized, and top 100 multinational MedTech companies.

Improving Public Health Care Through Regulatory Affairs

Operating for two decades, we have seen the need to combine the power of machine learning, the efficiency of data management, and the connectivity of a professional network into a new technology service platform. So, in 2013, we launched an integrated suite of cloud-based products designed to streamline, simplify, and expedite international regulatory affairs.  Our products and services connect medical device manufacturers, regulatory authorities, and industry experts through one global regulatory management system, LICENSALE.COM®.

By the end of 2018, LICENSALE.COM enabled hundreds of medical and IVD manufacturers to process over 3000 market registrations in 40 markets, including in the USA and the EU. LICENSALE.COM allows us to make significant progress by accelerating time-to-market for faster and equal public access to advanced medical products and practice, on a global scale.

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

– Benjamin Arazy

Year of Establishment

Companies Trust Arazy Group

Medical & IVD Device Registrations in over 125 Countries

Industry and Academic Opportunities   

Arazy Group MedTech Start-Up Initiative

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

Student Ambassador Program

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! 

Careers

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.

Industry and Academic Opportunities   

Arazy Group MedTech Start-Up Initiative

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

Student Ambassador Program

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! 

Careers

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.

Join one of our upcoming webinars:

Please check back for new webinars in January 2019. 

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.

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. “

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.”

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.”

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

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.

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.”