A case study released on the anniversary of medical device giant Elekta's work with Licensale.com revealed that just one year after its launch, Arazy Group's unique, online registration platform is a revolutionary regulatory asset for medical device manufacturers of all sizes.
Elekta is a human care company pioneering significant innovations and clinical solutions for treating cancer and brain disorders. Like many other manufacturers, Elekta previously focused mainly on major markets, 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 Licensale.com, 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, Licensale.com, Elekta processed regulatory approval for 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 year. This included registration of simple patient positioning devices, planning software, and high-risk stereotactic radiation therapy systems.
"When we do a project with Arazy Group, the Licensale.com system is the backbone of the registration process. Licensale.com 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.
"We are witnessing the rapid adoption of the platform by the industry," added Benjamin Arazy, CEO and President of Arazy Group. "Licensale.com handles the compliance and registration process of any type of medical or IVD product in over 80 countries, expediting registration and supporting manufacturers to maintain ownership of their licenses through our Global Authorized Representative infrastructure. While we work with Elekta on their global registration, thousands of other applications are currently being processed for companies from small start-ups to multinationals."
"We are able to approach new opportunities with confidence that we can find a solution to the challenge," continued Mr. Yard.
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