{"id":2070,"date":"2021-09-17T17:23:18","date_gmt":"2021-09-17T15:23:18","guid":{"rendered":"https:\/\/hg-medical.de\/?page_id=2070"},"modified":"2023-12-13T10:44:30","modified_gmt":"2023-12-13T09:44:30","slug":"quality-regulatory","status":"publish","type":"page","link":"https:\/\/hg-medical.de\/en\/solutions\/quality-regulatory\/","title":{"rendered":"Quality & Regulatory"},"content":{"rendered":"\t\t
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Quality & Regulatory<\/h3>\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<\/div>\n\t\t\t\t
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EN ISO 13485:2016 + AC:2018 + A11:2021
\r\nFDA 21 CFR Part 820 <\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Independant and constantly audited production sites in Germany and the USA.<\/p>\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\thg medical GmbH ISO 13485:2021 \u201cEnglish\u201d<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\thg medical GmbH ISO 13485:2021 \u201cGerman\u201d<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\thg medical LLC ISO 13485:2016 \u201cEnglish\u201d<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\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<\/div>\n\t\t\t\t
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\"\"<\/div><\/div>
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Quality management at hg medical<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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hg medical runs on both production sites completely independent quality management systems. Both hg medical subsidiaries are ISO 13485:2016 certified. Of course both sites act according FDA 21 CFR Part 820 and have seen full FDA audits.<\/p>\n

Our internal audits are performed ongoing and regulary. In addition to that, we see multiple customer audits every year. When you enter our production halls, you feel the sense for quality every single time. As an OEM, you know this all is not easy to explain in words. Come and test us!<\/p>\n<\/div>\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<\/div>\n\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<\/div>\n\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<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

LOREM IPSUM DOLOR SIT AMETLorem ipsum dolor sit amet, consetetur sadipscing elitr, sed diam nonumy eirmod tempor invidunt ut labore et dolore magna aliquyam erat, sed diam voluptua. At vero eos et accusam et justo duo dolores et ea rebum. Stet clita kasd gubergren, no sea takimata sanctus est Lorem ipsum dolor sit amet. 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