AnazaoHealth™ Corporation Receives
International Quality Standard Certification
TAMPA, FLORIDA, July 22, 2005 — AnazaoHealth™ Corporation, based in Tampa, Florida, recently achieved ISO-13485 certification, the international quality standard for medical device manufacturers. AnazaoHealth Corporation is the first pharmacy in the United States to achieve this certification.
AnazaoHealth Corporation provides services and treatments domestically. While the corporation is not a medical device manufacturer, it does adhere to international standards as it fills prescriptions for the Brachytherapy industry. “AnazaoHealth is dedicated to customized Brachytherapy treatments for patients with prostate, breast and eye cancers,” said Jacob Beckel, Chairman and CEO, AnazaoHealth Corporation. “We are dedicated to create and provide the most powerful innovations in healing for our patients and with this certification; we are better able to serve our clients and their patients by providing faster, more efficient service.”
AnazaoHealth chose to apply for this prestigious certification to follow their company vision of remaining a leader in industry standards by providing the highest level of patient safety and quality assurance. Requests from clients played a significant role in their decision of international expansion.
Brachytherapy seed manufacturers have expanded their services and have begun supplying products in the European market. Because AnazaoHealth provides these seed manufacturers with the prescriptions they need to treat patients, the manufacturers made repeated requests for AnazaoHealth to obtain the ISO-13485 certification.
AnazaoHealth Corporation, headquartered in Tampa, Florida, is a privately held specialty pharmacy focusing on customized preparations serving the Brachytherapy, nuclear medicine and pain management markets, as well as providing drugs used in clinical trials. AnazaoHealth is licensed to practice pharmacy in all 50 states, the District of Columbia and Puerto Rico, and provides high quality prescription medications to doctors, pain clinics and hospitals. AnazaoHealth includes a Nuclear Medicine Division, Brachytherapy Division, Pain Management Division and a Custom Pharmacy Division.
In order to achieve the ISO-13485 certification, medical corporations must undergo a rigorous audit of their operation procedures and quality control systems and standards by a Notified Body of the International Standards Organization.
A Notified Body is an organization that has been nominated by a member Government and Notified by the European Commission. The role of a Notified Body is to provide services for conformity assessment on the conditions set out in the New Approach Directives in support of CE marking. Conformity assessment can be inspection, quality assurance, type examination or design examination.
Aspects that were examined in the AnazaoHealth Corporation audit included: document and data control; control of quality records; training; the prescription renewal process; the inspecting and testing of prescriptions; and the handling, storage, package and delivery of prescriptions.
“Achieving the ISO-13485 certification allows expanded opportunities for us to meet the world-wide demand for patient specific Brachytherapy treatments,” McKenzie added.