{"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-le-document-de-conception","status":"publish","type":"docs","link":"https:\/\/gutehospitalpraxis.de\/fr\/handbuch\/5-pruefung\/5-2-analyse-und-validierung\/5-2-12-das-design-dokument\/","title":{"rendered":"5.2.12 Le document de conception"},"content":{"rendered":"<h2 class=\"wp-block-heading\" id=\"zweck_und_ziel\">But et objectif<\/h2>\n\n\n\n<p>Cr\u00e9ation d'un document contenant les r\u00e9sultats du d\u00e9veloppement d'un produit (prestation m\u00e9dicale) comme preuve que<\/p>\n\n\n\n<p>a) les exigences contenues dans les soumissions de d\u00e9veloppement sont respect\u00e9es,<br>b) les processus qui s'ensuivent sont appropri\u00e9s pour fournir le produit (le service, le traitement m\u00e9dical),<br>c) toutes les exigences en mati\u00e8re de surveillance et de mesure, le cas \u00e9ch\u00e9ant, ainsi que les crit\u00e8res d'acceptation sont inclus,<br>d) les \u00e9l\u00e9ments de preuve relatifs aux caract\u00e9ristiques de qualit\u00e9 sont suffisants pour d\u00e9montrer la fonctionnalit\u00e9 des produits pour l'usage pr\u00e9vu et une mise \u00e0 disposition s\u00fbre et correcte.<\/p>\n\n\n\n<p>L'\u00e9tendue du dossier de v\u00e9rification est d\u00e9finie. Le dossier de v\u00e9rification scientifique est accompagn\u00e9 d'un cahier des charges, des r\u00e9sultats de la v\u00e9rification de l'absence d'erreurs techniques et des informations d'utilisation correspondantes.<\/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 du d\u00e9roulement<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"beschreibung\">Risques<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"dokumentation\">Ressources <\/h2>\n\n\n\n<h4 class=\"wp-block-heading\">Mat\u00e9riau<\/h4>\n\n\n\n<h4 class=\"wp-block-heading\">Temps n\u00e9cessaire<\/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\">Comp\u00e9tence et qualification<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"hinweise_und_anmerkungen\">Remarques et commentaires<\/h2>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"mitgeltende_unterlagen\">Documents \u00e0 joindre<\/h2>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"literatur\">Documents de validation<\/h4>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"begriffe\">Termes<\/h4>\n\n\n\n<p><\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"anlagen\">Placements<\/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\/fr\/wp-json\/wp\/v2\/docs\/11018","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/docs"}],"about":[{"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/types\/docs"}],"author":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/comments?post=11018"}],"version-history":[{"count":1,"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/docs\/11018\/revisions"}],"predecessor-version":[{"id":15074,"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/docs\/11018\/revisions\/15074"}],"up":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/docs\/10952"}],"wp:attachment":[{"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/media?parent=11018"}],"wp:term":[{"taxonomy":"doc_tag","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/doc_tag?post=11018"},{"taxonomy":"doc_badge","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/fr\/wp-json\/wp\/v2\/doc_badge?post=11018"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}