{"id":4139,"date":"2023-03-07T08:08:08","date_gmt":"2023-03-07T00:08:08","guid":{"rendered":"https:\/\/regask.com\/?p=4139"},"modified":"2024-10-15T00:55:10","modified_gmt":"2024-10-14T16:55:10","slug":"fda-leitfaden-fur-rontgendiagnostik","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/fda-diagnostic-x-ray-guidance\/","title":{"rendered":"US-amerikanische FDA ver\u00f6ffentlicht Leitlinien zum \u201eAssembler\u2019s Guide\u2026\u201c"},"content":{"rendered":"
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Dieses Dokument ersetzt den Assembler-Leitfaden f\u00fcr diagnostische R\u00f6ntgenger\u00e4te: Verantwortlichkeiten von Monteuren, Distributoren und H\u00e4ndlern von diagnostischen R\u00f6ntgenger\u00e4ten gem\u00e4\u00df dem Bundesleistungsstandard (DHHS-Ver\u00f6ffentlichung FDA 81-8144, November 1980).<\/div>\n
<\/div>\n
Es enth\u00e4lt Empfehlungen zu den allgemeinen Verantwortlichkeiten von Herstellern und Monteuren diagnostischer R\u00f6ntgenger\u00e4te sowie zu den Richtlinien f\u00fcr die Montage zertifizierter diagnostischer R\u00f6ntgenger\u00e4te.<\/div>\n
<\/div>\n
Hersteller und Monteure diagnostischer R\u00f6ntgenger\u00e4te sollten diese Empfehlungen ber\u00fccksichtigen, da sie die aktuelle Auffassung der FDA zu diesem Thema widerspiegeln.<\/div>\n<\/div>\n
<\/div>\n
M\u00f6chten Sie mehr \u00fcber \u00c4nderungen der Vorschriften f\u00fcr Medizinprodukte erfahren? Nehmen Sie Kontakt mit den Experten von RegASK auf.<\/a><\/div>\n
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\n\t\t\t\n\t\t\t\n\n\t\tLesen Sie Fallstudien aus der Medizinger\u00e4tebranche<\/span>\n\t<\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"

This document supersedes Assembler’s guide to diagnostic x-ray equipment: responsibilities of assemblers, distributors, and dealers of diagnostic x-ray equipment under the federal performance standard (DHHS Publication FDA 81-8144, November 1980). It provides recommendations on the general responsibilities of manufacturers and assemblers of diagnostic x-ray equipment and the policy on the assembly of certified diagnostic x-ray…<\/p>","protected":false},"author":39,"featured_media":2976,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[39],"tags":[40],"class_list":["post-4139","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-devices-insights","tag-latest-insights"],"acf":[],"yoast_head":"\nFDA Diagnostic X-Ray Guidance | RegASK<\/title>\n<meta name=\"description\" content=\"The US FDA issues new guidance for assemblers of diagnostic X-ray equipment. Stay compliant with RegASK.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/de\/fda-leitfaden-fur-rontgendiagnostik\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"US FDA Issues Guidance of "Assembler's Guide to Diagnostic X-Ray Equipment"\" \/>\n<meta property=\"og:description\" content=\"The US FDA issues new guidance for assemblers of diagnostic X-ray equipment. 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