{"id":9801,"date":"2022-06-08T12:31:57","date_gmt":"2022-06-08T10:31:57","guid":{"rendered":"https:\/\/stephanix.com\/?page_id=9801"},"modified":"2025-12-18T17:48:16","modified_gmt":"2025-12-18T16:48:16","slug":"certifications-awards","status":"publish","type":"page","link":"https:\/\/stephanix.com\/en\/certifications-awards\/","title":{"rendered":"Certifications & Awards"},"content":{"rendered":"\t\t
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Certifications & Awards<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Thanks to our know-how, we have been able to conquer the French radiology market and continue our development well beyond.\u00a0<\/p>

Our systems are CE marked and are registered for the most part with the FDA, Health Canada and the SFDA, allowing us to sell our products in more than 100 countries and achieving 30% of our sales internationally.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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ISO 13485 certification is a voluntary quality management system certification for medical device companies to meet applicable regulatory requirements.<\/p> <\/div>\n\n \n \tDownload our ISO 13485 certification <\/a>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n \t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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ISO 9001 certification is a voluntary certification of the quality management system based mainly on the improvement of customer satisfaction and its processes.<\/p> <\/div>\n\n \n \tDownload our ISO 9001 certification <\/a>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n \t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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The Medical Device Single Audit Program is an international quality management systems assessment program that verifies our compliance with regulatory requirements in the following two markets:\u00a0 Canada and the United States.<\/p> <\/div>\n\n \n \tDownload our ISO MDSAP 13485 certification <\/a>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n \t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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STEPHANIX DOUBLE CERTIFIED<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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D\u00b2RS x-ray remote controlled table<\/h4>
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“Origine France Garantie”<\/strong>\u00a0is the only certification that attests the French origin of a product.<\/p>

It assures consumers of the traceability of the product by giving a clear and objective indication of its origin.<\/p> <\/div>\n\n \n Download our Origine France Garantie certificate for our D\u00b2RS x-ray remote controlled tables <\/a>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n \t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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After-sales service<\/h4>
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“Service France Garanti” certification enable to promote service companies employing in France. This certification is a guarantee of transparency, proximity and quality.<\/p> <\/div>\n\n \n Download our Service France Garanti certificate for our after-sales service <\/a>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n \t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Origine France Garantie certification<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Since 2014, STEPHANIX holds the “Origine France Garantie” certification for its D\u00b2RS remote-controlled tables. We are the first company in the medical imaging sector to obtain this certification for ours D\u00b2RS<\/a><\/strong> x-ray remote-controlled tables.<\/p>

The certification is based on two cumulative criteria that companies must reach:<\/p>