Arazy Group Consultants Inc.

Arazy Group Consultants는 여러 대륙에 걸친 국제 컨설팅 업체로서 의료기기 및 IVD기기 회사가 새로운 시장에 진입하려고 할 때 규정 준수 및 업무를 지원합니다. 1995 년에 설립 된 Arazy Group은 전 세계 140 개국 이상에서 운영되고 있습니다. Arazy Group은 창업 초기, 중간 규모 및 상위 100 개 다국적 MedTech 기업에 서비스를 제공해 왔습니다.

규제 업무를 통한 공중 보건 개선

20여 년 동안 운영 되어오면서, 우리는 머신 러닝의 힘, 데이터 관리의 효율성 및 전문 네트워크의 새로운 기술 서비스 플랫폼으로의 연결성을 결합해야 할 필요성을 느꼈습니다. 이에 2013 년에는 국제 규제 업무를 간소화하고 간소화하며 신속하게 처리 할 수 있는 클라우드 기반 제품을 출시했습니다. 당사의 제품 및 서비스는 하나의 글로벌 규정 관리 시스템 인 LICENSALE.COM®을 통해 의료 장비 제조업체, 규제 당국 및 업계 전문가를 연결합니다.

LICENSALE.COM은 2018년 말까지 수백 개의 의료기기 및 IVD기기 제조업체가 미국 및 EU를 비롯한 40 개 시장에서 3000 건 이상의 시장 등록을 처리 할 수 있게 도왔습니다. LICENSALE.COM은 전 세계적 규모의 첨단 의료 제품 및 행위에 대한 보다 신속하고 평등 한 대중의 접근을 위해 출시 기간을 단축함으로써 상당한 발전을 이루었습니다.

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

– Benjamin Arazy

년 설립 년도

회사 신뢰 Arazy Group

125 개국 이상의 의료기기 및 IVD기기 등록

Industry and Academic Opportunities

Arazy Group MedTech 스타트업 이니셔티브
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

학생 앰버서더 프로그램
MedTech 산업을 앞당기려면? LICENSALE University Outreach Program은 대학 및 산업 간의 격차를 해소하는 데 도움이됩니다. MedTech 등록에서 제공되는 가장 앞선 기술에 대한 통찰력을 얻으십시오.

이것은 학생들에게 다음과 같은 좋은 기회입니다.

이력서 작성을 위한 귀중한 자원 봉사 경험을 얻으십시오.

미래 성장을 위한 업계 연결

대중 연설 및 지도력 향상

전세계의 더 많은 환자를 돕기 위한 새로운 규제 업무 기술에 대한 인식 제고

관심이 있으시면 문의하십시오!

채용 정보
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!

Industry and Academic Opportunities

Arazy Group MedTech 스타트업 이니셔티브
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

학생 앰버서더 프로그램
MedTech 산업을 앞당기려면? LICENSALE University Outreach Program은 대학 및 산업 간의 격차를 해소하는 데 도움이됩니다. MedTech 등록에서 제공되는 가장 앞선 기술에 대한 통찰력을 얻으십시오.

이것은 학생들에게 다음과 같은 좋은 기회입니다.

이력서 작성을 위한 귀중한 자원 봉사 경험을 얻으십시오.

미래 성장을 위한 업계 연결

대중 연설 및 지도력 향상

전세계의 더 많은 환자를 돕기 위한 새로운 규제 업무 기술에 대한 인식 제고

관심이 있으시면 문의하십시오!

채용 정보
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.

전시회

RAPS REGULATORY CONVERGENCE

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

DATE: September 23rd to 24th, 2019 

Unable to Meet Us in Person?

Schedule your online personal demonstration now!

Events

2019 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

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.