Medical Device Manufacture in Just One Year -- MEDICA - World Forum for Medicine


Arazy Group - Medical Device Consultant

Medical Device Manufacture in Just One Year

Elekta is a human care company pioneering significant innovations and clinical solutions for treating cancer and brain disorders. Like many other manufacturers, Elekta had previously focused mainly on the major markets of the world, including Europe, North America, and countries like Brazil and China.

When Elekta looked for new opportunities for growth in a changing global economy, they found a solution in, which offers cloud-based, online registration of multiple devices in multiple markets, simultaneously. Elekta was faced with a number of challenges, including unfamiliar regulatory environments in new markets, lack of regulatory resources on the ground, and slow time-to-market.

Working with Arazy Group and their flagship service,, Elekta was able to process regulatory approval for a staggering 78 products in 16 countries, including Bahrain, Cuba, Egypt, Honduras, Israel, Jordan, Kazakhstan, Macedonia, Russia, Saudi Arabia, the United Arab Emirates, and Yemen in less than a single year.

“When we do a project with Arazy Group, the system is the backbone of the registration process. meets the long-term demands of Elekta because it provides the regulatory flexibility necessary to meet the priorities of Elekta’s sales teams,” said Jon Yard, Elekta’s Director of Quality Assurance and Regulatory Affairs for the EU, Africa, Latin America, and the Middle East.

“One of the major barriers in the path of global registration for manufacturers is a lack of international infrastructure, which can be overwhelmingly complex and prohibitive in cost for both small start-ups and large corporations like Elekta. With, Elekta was able to utilise the expertise of Arazy Group specialists in over 80 countries worldwide, expediting registration and maintaining ownership of their own licenses with Arazy Group’s Global Authorized Representative service,” said Benjamin Arazy, CEO and President of Arazy Group.

“Contracting Arazy Group means that we work with a small group of regulatory professionals and we are able to develop relationships based on trust,” continued Mr. Yard, “We are able to approach new opportunities with confidence that we can find a solution to the challenge.” is offered today as the only service of its kind. The full case study and more information about can be found at