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Manufacturers of medical devices face enormous challenges. To have their medical devices approved for the market, they must comply with an almost limitless number of directives, statutory requirements and regulations regarding safety and quality. Who supports manufacturers in assuring the quality of their products? Who paves the way to their smooth market access? The experts at TÜV SÜD.
TÜV SÜD has a worldwide network, which includes scientists, medical engineers, quality management experts and experts in standards and codes. Not only have we served more than 4000 clients in the world, but also have awarded certificates to two-thirds of surgery implantation products global after assessment to their compliance.
Since the first CE certificate for medical devices is awarded in China, the Medical and Health Care Department of our company has supplied professional and painstaking service for a lot of medical devices companies through inspection and certification to their products and quality management system. 80% famous companies have chosen TÜV SÜD as their technical partner for the long term.
In China, we have more than 40 professional staff working for medical devices certification. Among them, more than 30 senior experts have received the highest esteemed training in Germany to gain authorities in the area of sterilisation, microorganism, metal materials, polymer materials, electrical safety, functional safety and clinical evaluation. They can help you optimise your process, reduce risks and improve your company’s capability of rapid reaction to the market demand. What’s more, our experts can even provide help in the product-designing stage, so that your products would not be postponed to come into the market because of repeated designing.
In China, TÜV SÜD has established steady long-term partnerships with Chinese medical devices supervisor authorities, competent departments of local governments, national inspection laboratories and research institutions.
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