PETACH TIKVA, Israel, April 9 /PRNewswire/ -- Orthocrat Ltd, a leading provider of orthopedic preoperative digital templating software, announced today that they have received two additional international certifications that attest to the safety and quality of their products through ISO 13485:2003 and CE certification as per directive 93/42/EEC. Orthocrat earned the certifications after a thorough review process, including on-site inspections, by Kema Quality B.V., one of the most respected European notified bodies specializing in testing and certification.
“In the very regulated and competitive medical industry, it is critical that medical device companies employ the most stringent quality standards,” says Zeev Glozman, CEO of Orthocrat. “With ISO and CE certification, in addition to the FDA clearance we received in the United States, we now have a global stamp of approval on our safety, performance, and efficacy standards. Our goal is to give our customers the highest level of confidence in the products they use everyday to improve patients’ lives.”
The CE mark is a mandatory certification for any product sold in the European community. CE certification indicates that after an assessment is made by an outside Notified Body, Traumacad, Orthocrat’s preoperative planning tool, complies with the essential requirements set out in European directives related to medical devices.
ISO 13485:2003 is an international standard designed to provide medical device companies with a common approach to applying quality management systems. In order to obtain ISO certification, Orthocrat was required to establish a quality control system based on a “process approach” to ensure its ability to provide medical devices that consistently meet customer and regulatory requirements.
“While many other companies in our industry have sufficed with a self-declared CE-Mark and no ISO certification, Orthocrat believes it is of utmost importance to build trust in our products through the highest level of certification,” said Ian Wilson, Orthocrat’s VP of Sales for Europe. “Our current certifications demonstrate that Orthocrat is well positioned to be a competitive player in the European market.”
About Orthocrat
Orthocrat was founded in 2003 by Zeev Glozman, an entrepreneur, and Dr. Doron Noman, the Deputy Director of the Department of Orthopedics and Traumatology from the Rambam Medical Center in Haifa, Israel. The company’s mission is to advance the orthopedic community to a 100% filmless work mode. Orthocrat’s flagship software product, Traumacad, enables surgeons to accurately measure implant sizes from digital images, making their surgeries more efficient and effective. Traumacad has been installed in over 700 hospitals, research centers and clinics in the US, Europe and Israel. For more information please see http://www.orthocrat.com.
Established in 1927, KEMA is a commercial enterprise, specializing in high-grade business and technical consultancy, inspections and measurement, testing and certification. Much of the company’s work centers round innovative technology. KEMA Quality is one of the larger Notified Bodies in the EC for the Medical Device Directive, the Active Implantable Medical Device Directive and the In Vitro Diagnostic Directive. KEMA has also been recognized for conducting ISO 13485 audits and Certification for the Canadian market. Kema is one of the few approved FDA third party reviewers for 510(K) submissions. For more information please see http://www.kema.com.
CONTACT: Media Contact: Ruder Finn Israel for Orthocrat, Jordana Miller,
Tel: +972-544-676-979, Email: jordana@ruderfinn.co.il
