About the Arazy Group
Our expertise is regulatory affairs and quality assurance for the medical device industry. We specialize in marketing safe and effective Medical Technology to international markets. Our experienced consultants are responsible for the successful registration of thousands of medical devices globally. Our customized solutions accommodate all stages of medical device’s life cycle and our adaptable services fit any application and any size organization.

Our Experience
For more than 15 years, our professional consultants have utilized validation, verification and regulation processes on a diverse portfolio of medical devices. 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, Dental Lab Products, General Hospital Equipment.

Our Success


We offer registration of medical device services in more than 53 countries. Arazy Group has gained market clearance for medical devices and IVDs in North and South America (USA, Canada, Mexico, Argentina, Brazil, Chile, Columbia, Peru, Venezuela), most European countries including Russia, various Asian markets (Israel, Saudi Arabia, Turkey, China, Hong Kong, India, Indonesia, Japan, Korea, Pakistan, Singapore, Taiwan, Thailand), Africa (Algeria, Egypt, Kenya, South Africa) and Australia (Australia, New Zealand). We have an established reputation as professional FDA consultants and our quality work has successfully passed numerous audits and inspections by the leading European Notified Bodies as well as other world health authorities.

Our Team


Our Team consists of scientists, medical experts, regulatory specialists, clinical researchers and quality assurance managers from around the world who have excelled in both the Medical Device and the IVD industries. Our Team leaders and regional managers possess multi-disciplinary knowledge rooted in at least eight to ten years of successful regulatory affairs and quality assurance experience. Our consultants go through multi-stage interview process to qualify as an Arazy Group expert. In addition, many new recruits are subjected to demanding training and qualification program.

At The Arazy Group, we are passionate about the regulatory and the quality field and take pride in our work to facilitate the penetration of safe and effective devices into global markets. Our services are available in multiple languages. A local or an online Arazy Group consultant is ready to assist you.