{"id":3861,"date":"2026-05-21T22:27:50","date_gmt":"2026-05-21T20:27:50","guid":{"rendered":"https:\/\/ict-improve.nl\/training\/medical-grade-software-development-nl\/medical-grade-software-development\/"},"modified":"2026-05-22T09:36:27","modified_gmt":"2026-05-22T07:36:27","slug":"medical-grade-software-development","status":"publish","type":"training","link":"https:\/\/ict-improve.nl\/en\/training\/medical-grade-software-development-nl\/medical-grade-software-development\/","title":{"rendered":"Medical Grade Software Development"},"content":{"rendered":"","protected":false},"excerpt":{"rendered":"<p>Na deze training kun je: CE-markeringsaspecten vanuit de Medical Device Regulation (MDR) uitleggen Softwarelevenscyclusprocessen volgens IEC 62304 begrijpen Veiligheidsrisicomanagement volgens ISO 14971 toepassen Bruikbaarheidsengineering volgens IEC 62366-1 begrijpen Agile werkwijzen toepassen binnen softwareontwikkeling voor medische hulpmiddelen Zorgen dat Medical Grade Software voldoet aan de Europese regelgeving, waaronder de MDR, wordt vaak onderschat. Je moet onder andere je software classificeren, bepalen welke vereisten en normen van toepassing zijn, je softwareontwikkeling plannen, risicobeoordelingen uitvoeren, je software testen, bruikbaarheidstesten uitvoeren en zorgen voor gedocumenteerd bewijs. Deze eendaagse training geeft je een overzicht van de regelgeving en normen voor Medical Grade Software en biedt praktische kennis over hoe je de vereisten van de MDR (Medical Device Regulation) en de toepasselijke normen kunt toepassen in je softwareontwikkelproces. Deze training is geschikt voor Medical Grade Software engineers, projectmanagers, product owners, quality engineers, regulatory engineers en management van fabrikanten en leveranciers van Medical Grade Software. De training is bedoeld voor professionals met bachelor- of masterniveau, of vergelijkbare kennis opgedaan door ervaring. Opzet van de training CE Marking en MDR: de basis van Europese wet- en regelgeving Kwalificatie en classificatie: wanneer valt je product onder de MDR? General Safety and Performance Requirements (GSPR): hoe voldoe je aan de<\/p>\n","protected":false},"featured_media":0,"parent":3844,"menu_order":99991231,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}}},"class_list":["post-3861","training","type-training","status-publish","hentry"],"acf":{"start_date":null,"duration":"","price":"\u20ac 795,- Excl. 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