Arazy Group Consultants Inc.

Arazy Group Consultants es una consultora internacional que abarca varios continentes, asistiendo a compañías de dispositivos médicos e IVD en el cumplimiento y los asuntos regulatorio, a medida que intentan ingresar a nuevos mercados. Fundada en 1995, Arazy Group opera en más de 125 países alrededor del mundo. Arazy Group ha prestado servicios a empresas start-ups, medianas, y top 100 de Tecnología Médica.

Mejorando la Salud Pública a través de los asuntos regulatorios

Operando durante dos décadas, hemos visto la necesidad de combinar el poder del machine learning, la eficiencia de la gestión de datos y la conectividad de una red profesional en una nueva plataforma de servicios de tecnología. Entonces, en 2013, lanzamos un conjunto integrado de productos basados en la nube diseñados para reorganizar, simplificar y acelerar los asuntos regulatorios internacionales. Nuestros productos y servicios conectan a fabricantes de dispositivos médicos, autoridades reguladoras y expertos de la industria a través de un sistema de gestión regulatoria global, LICENSALE.COM®.

Para fines de 2018, LICENSALE.COM había permitido a cientos de fabricantes médicos e IVD procesar más de 3000 registros de mercado en 40 mercados, incluidos los EE. UU. y la UE. LICENSALE.COM nos permite hacer un progreso significativo al acelerar el tiempo de llegada al mercado, para un acceso del público más rápido e igualitario a productos y prácticas médicos avanzados, a escala global.

«Acelere el tiempo de llegada al mercado, para un acceso del público más rápido e igualitario a productos y prácticas médicos avanzados, a escala global.»

– Benjamin Arazy

Año de creación

Empresas que confían Arazy Group

Registros de dispositivos médicos e IVD en 140 países

Industria y oportunidades académicas.   

Iniciativa Arazy Group para Start-ups de Tecnología Médica
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

Programa Embajador Estudiantil
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! 

Carreras

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 [email protected] 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!

Industria y oportunidades académicas.   

Iniciativa Arazy Group para Start-ups de Tecnología Médica
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

Programa Embajador Estudiantil
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! 

Carreras

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 [email protected] with the subject line “Arazy Group Career Opportunities”.

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

Exposiciones

RAPS REGULATORY CONVERGENCE

Arazy Group was in Philadelphia this year for the 2019 MedTech Regulatory Awards.

DATE: September 23rd to 24th, 2019 

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Eventos

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.

Arazy Group  – One World Process

Formulario de consulta


* 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

LICENSALE Client Luminex's Logo

“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

Licensale Client Swiss Precision Diagnostics' logo

«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

LICENSALE Client Elekta's Logo

«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.

LICENSALE Client Visionsense's Logo

«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

LICENSALE Client Hanin Medical Center's Logo

“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.