{"id":139,"date":"2022-11-18T14:10:21","date_gmt":"2022-11-18T14:10:21","guid":{"rendered":"http:\/\/qcloop.de\/?page_id=139"},"modified":"2025-05-19T10:01:49","modified_gmt":"2025-05-19T10:01:49","slug":"referenzen","status":"publish","type":"page","link":"https:\/\/qc-loop.de\/en\/referenzen\/","title":{"rendered":"References"},"content":{"rendered":"
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<\/div>\n\t\t<\/div>\n\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\t\t\t\t\t\t\t\t\t\t\"illustration\t\t\t\t\t\t\t\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
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Schulungen, Workshops &
Personal Compliance Training (PCT):<\/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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Qualit\u00e4tsmanagementsysteme<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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ISO 9001:2015<\/p>

ISO 13485:2016<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Risk Management<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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ISO 14971:2019<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Medical Device Regulation in Europe<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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EU 2017\/745 (MDR) – Pflichten der Wirtschaftsakteure<\/p>

\u00a0<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Medizinprodukterecht in Europa - Grundlagen<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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rechtlicher Rahmen f\u00fcr Konformit\u00e4tsbewertungsverfahren<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Interne Audits \/ Lieferantenaudits\n<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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ISO 19011:2018<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Lieferantenmanagement<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Zulassung & \u00dcberwachung von Lieferanten<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Medizinprodukteberater<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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MPDG \u00a783 – Nachweis gem\u00e4\u00df BV-Med<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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PRRC - Person Responsible for Regulatory Compliance
<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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EU 2017\/745, Artikel 15: Die f\u00fcr die Einhaltung der Regulierungsvorschriften verantwortliche Person<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Technische Dokumentation f\u00fcr Medizinprodukte<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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EU 2017\/745, Anhang II & III – GHTF STED – IMDRF nIVD ToC<\/p>

\u00a0<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Zulassung von Medizinprodukten in den USA
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FDA’s Anforderungen an Zulassungsdokumentation, Technischer Dokumentation und Qualit\u00e4tsmanagementsysteme<\/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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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t<\/i>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\tBack to top<\/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>","protected":false},"excerpt":{"rendered":"

Schulungen, Workshops & Personal Compliance Training (PCT): Qualit\u00e4tsmanagementsysteme ISO 9001:2015 ISO 13485:2016 Risikomanagement ISO 14971:2019 Medical Device Regulation in Europe EU 2017\/745 (MDR) – Pflichten der Wirtschaftsakteure \u00a0 Medizinprodukterecht in Europa – Grundlagen rechtlicher Rahmen f\u00fcr Konformit\u00e4tsbewertungsverfahren Interne Audits \/ Lieferantenaudits ISO 19011:2018 Lieferantenmanagement Zulassung & \u00dcberwachung von Lieferanten Medizinprodukteberater MPDG \u00a783 – Nachweis gem\u00e4\u00df […]<\/p>","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"inline_featured_image":false,"footnotes":""},"class_list":["post-139","page","type-page","status-publish","hentry"],"yoast_head":"\nReferenzen - qc-loop.de<\/title>\n<meta name=\"description\" content=\"Eine Auswahl von Projekten als Referenzen von QC Loop im Bereich Qualit\u00e4tsmanagement\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/qc-loop.de\/en\/referenzen\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Referenzen - 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