{"id":11018,"date":"2024-12-11T15:16:24","date_gmt":"2024-12-11T14:16:24","guid":{"rendered":"https:\/\/extali.eu\/docs\/5-pruefung\/5-2-analyse-und-validierung\/5-2-12-das-design-dokument\/"},"modified":"2025-02-04T13:38:11","modified_gmt":"2025-02-04T12:38:11","slug":"5-2-12-the-design-document","status":"publish","type":"docs","link":"https:\/\/gutehospitalpraxis.de\/en\/handbuch\/5-pruefung\/5-2-analyse-und-validierung\/5-2-12-das-design-dokument\/","title":{"rendered":"5.2.12 The design document"},"content":{"rendered":"<h2 class=\"wp-block-heading\" id=\"zweck_und_ziel\">Purpose and goal<\/h2>\n\n\n\n<p>Creation of a document with the development results for a product (medical service) as proof that<\/p>\n\n\n\n<p>a) the requirements contained in the development submissions are met,<br>b) the subsequent processes for providing the product (service, medical treatment) are suitable,<br>c) all monitoring and measurement requirements, where applicable, and acceptance criteria are included,<br>(d) the evidence on the quality characteristics is sufficient to demonstrate the functionality of the devices for the intended purpose and a safe and proper provision.<\/p>\n\n\n\n<p>The scope of the verification documents is defined. A specification sheet, the results of the test for technical accuracy and the associated user information are attached to the scientific test documents.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"anwendungsbereich\">Application<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"beschreibung\">Description of the process<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"beschreibung\">Risks<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"dokumentation\">Resources <\/h2>\n\n\n\n<h4 class=\"wp-block-heading\">Material<\/h4>\n\n\n\n<h4 class=\"wp-block-heading\">Time required<\/h4>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"ressourcen\">Documentation<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"zustaendigkeit_und_qualifikation\">Responsibility and qualification<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"hinweise_und_anmerkungen\">Notes and comments<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"mitgeltende_unterlagen\">Applicable documents<\/h2>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"literatur\">Validation documents<\/h4>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"begriffe\">Terms<\/h4>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"anlagen\">Attachments<\/h2>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>Zweck und Ziel Erstellung eines Dokumentes mit den Entwicklungsergebnissen zu einem Produkt (medizinische Leistung) als Beleg daf\u00fcr, dass a) die in den Entwicklungseingaben enthaltenen Anforderungen erf\u00fcllt werden,b) die sich anschlie\u00dfenden Prozesse zur Bereitstellung des Produktes (der Dienstleistung, medizinischen Behandlung) geeignet sind,c) alle Anforderungen an die \u00dcberwachung und Messung, soweit zu-treffend, sowie Annahmekriterien enthalten sind,d) das [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":10952,"menu_order":47,"comment_status":"open","ping_status":"closed","template":"","doc_tag":[],"doc_badge":[],"class_list":["post-11018","docs","type-docs","status-publish","hentry","no-post-thumbnail"],"acf":[],"author_avatar":"https:\/\/secure.gravatar.com\/avatar\/c6b2616140d9fcd6a1c5d6d2ebbf43422308c9322c032ef03f88ec3235855dcf?s=96&d=mm&r=g","author_name":"admin","_links":{"self":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/11018","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs"}],"about":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/types\/docs"}],"author":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/comments?post=11018"}],"version-history":[{"count":1,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/11018\/revisions"}],"predecessor-version":[{"id":15074,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/11018\/revisions\/15074"}],"up":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/10952"}],"wp:attachment":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/media?parent=11018"}],"wp:term":[{"taxonomy":"doc_tag","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_tag?post=11018"},{"taxonomy":"doc_badge","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_badge?post=11018"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}