Israel Medical Innovation - Israeli-South African Trade, Technology ...

Israel Medical Innovation2011
Arazy Group
www.arazygroup.com
Category:
Services
Company Status:
Revenue Growth
Company at a Glance
The Arazy Group expertise is regulatory affairs and quality assurance for the medical
device industry.
Arazy Group offers medical device registration services in more than 53 countries and have
gained market clearance for medical devices and IVDs in North and South America, most
European countries, various Asian markets, MENA, Africa and Australia. We implement
advance global regulatory products that enable our client to overcome the traditional;
multiple-country regulatory compliance that is currently achieved through multiplesubmission
processes.
For more than 16 years, our professional consultants have utilized validation, verification
and regulation processes on a diverse portfolio of medical devices, and are responsible for
thousands of successful registrations globally. Our customized solutions accommodate all
stages of medical device’s life cycle and our adaptable services fit any application and any
size organization. We Expedite Success of Safe Medical Devices.
Technology and Product(s)
GlobaR – One World Process
Traditionally, multiple-country regulatory compliance is achieved through multiplesubmission
processes. The common practice is fragmented, inefficient, costly and time
consuming.
GlobaR regulatory intelligence system generates unique Global Master Regulatory File
for any medical device called a GlobaR dossier. The following registration process is
quick and efficient since this single file complies with international harmonized standards,
local standards and manufacturing quality management system, creating one universal
dossier which shows your device is safe and effective.
Whether you are seeking enter your device into one market or multiple markets, we have
the solution Our experts are often outsourced for quality and regulatory (QA/RA) positions
to design and implement regulatory strategy for some of the most advanced and complex
devices. Our past experiences comprise of successful registrations of various medical
device categories such as, Drug Delivery, Imaging and Navigation systems, Diagnostic
Software Energy emitting technology, Therapeutic Devices, Combination Devices, Active
and Passive Implants, Diabetic Products, IVDs, Surgical Disposables, Dental Implants and
Dental Lab Products.
Goal
Objectives: Increase client base and locating local agent in additional countries.
Target Businesses: Medical device manufactureres, regulatory affairs consultants and
R&D companies
Target Countries: Worldwide
Schedule a Meeting at
Return to Table of Content
18