UNITED STATES, SEPTEMBER 30 2014 – Arazy Group Consultants Inc. is pleased to announce the 510k clearance of the SAAD Patient Monitor from Hanin Medical in the USA, which follows the successful registration of the device in the EU in early 2013. The SAAD Patient Monitor is the first advanced patient monitor designed and manufactured in Saudi Arabia to obtain both CE Mark and FDA clearance.
“We were very excited to receive our 510k clearance for the SAAD Patient Monitor months earlier than anticipated with Arazy Group," said Rudolf Holzhausen from Hanin Medical. ”Arazy Group went above and beyond for this project and we are very happy with the result, which marks the first registration project of its kind in the USA and EU."
“We are very pleased to work with Hanin Medical to bring their product into major markets,” added Benjamin Arazy, President and CEO of Arazy Group. “As the first Saudi device of its kind to achieve these results, the registration process brought rare challenges requiring us to conduct validation testing and other specific services on behalf of the client. The recent approvals mark an important achievement for Arazy Group and Hanin Medical.”
Learn more about Arazy Group’s custom services and online registration system, LICENSALE.COM™ at licensale.com.