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12 Advanced medical solutions Valtech Cardio operates according to the surgical golden standard Advanced medical equipment that contributes to the welfare of cardiac patients is what the Israeli company Valtech Cardio is all about. The company operates according to the 'surgical golden standard'. Everything revolves around optimum quality. The R&D facilities at Valtech Cardio are located at Or Yehuda in Israel, near Tel Aviv. The specialists here work closely with DEKRA, both with the office in Arnhem and with the local DEKRA medical office. Local presence There is a dedicated team working for Valtech Cardio in Arnhem. DEKRA also has an office in the Israeli town of Kfar Saba, near Tel Aviv. This office is DEKRA’s local face in the market. DEKRA deliberately chooses to maintain a local presence. Many smaller offices have been set up around the world with specialists who know the market and can be on site rapidly to deal with any questions. The office in Israel has three project managers and a number of support staff. Angelien Beumer is the manager of the Israeli office. “There is a very active medical devices market here,” she says. “A local presence has many advantages. We’re flexible and on site quickly, understand the culture and speak the language. We’re also familiar with the market and can react to developments immediately. DEKRA’s head office is our base. We act as the bridge between two cultures.” Valtech Cardio focuses on the development of medical devices to improve the treatment of mitral regurgitation which is the most common cardiac valve disease. Valtech Cardio develops a range of devices used in open heart surgery as well as highly advanced products for transcatheter technology. In order to be sold in the EU, the products must comply with the European Medical Device Directive (MDD 93/42/EEC) and carry the CE mark. Valtech Cardio also required ISO 13485 certification for its quality management system. As a specialist in the medical field, DEKRA was able to offer a total solution. “We sought a company that could help us do some forward thinking in our development process,” says Asaf Azulay, VP Quality and Regulatory at Valtech Cardio. “By taking the right decisions in the development phase, we can avoid any discrepancies later Asaf Azulay, VP Quality and Regulatory: “DEKRA helps us to accomplish ambitious objectives”


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