{"id":2621,"date":"2023-04-07T12:28:23","date_gmt":"2023-04-07T12:28:23","guid":{"rendered":"https:\/\/wittepoel.nl\/site-ptl\/?page_id=2621"},"modified":"2025-10-23T10:29:00","modified_gmt":"2025-10-23T10:29:00","slug":"gesetze-und-verordnungen","status":"publish","type":"page","link":"https:\/\/pltproducts.nl\/de\/over-ons\/wet-en-regelgeving\/","title":{"rendered":"Recht und Regulierung"},"content":{"rendered":"<section class=\"section-breadcrumb\">\n    <div class=\"shell\">\n        <nav class=\"nav-breadcrumb\" data-aos=\"fade-right\">\n        \t        <\/nav><!-- \/.nav-breadcrumb -->\n    <\/div><!-- \/.shell -->\n<\/section><!-- \/.section-breadcrumb -->\n\n\n<section class=\"section-intro section-intro--mobile-style-secondary\" data-id=\"section-01\" style=\"\t--section-intro-heading-strong: #0096d2;\">\n\t\n    <div class=\"shell shell--flex\">\n    \t\t        <div class=\"section__aside js-fixed-aside\">\n\t            <div class=\"section__aside-group\">\n\t                <div class=\"section__aside-nav\" data-aos=\"fade-right\">\n\t                    <nav class=\"nav-aside js__nav\">\n\t                        <ul>\n\t                        \t\t\t                            <li class=\"active\">\n\t\t                                <a href=\"#section-01\">\n\t\t                                \tEinf\u00fchrung\t\t                                <\/a>\n\t\t                            <\/li>\n\t                        \t\t\t                            <li class=\"\">\n\t\t                                <a href=\"#section-02\">\n\t\t                                \tMDR-Gesetzgebung \t\t                                <\/a>\n\t\t                            <\/li>\n\t                        \t\t\t                            <li class=\"\">\n\t\t                                <a href=\"#section-03\">\n\t\t                                \tISO 13485\t\t                                <\/a>\n\t\t                            <\/li>\n\t                        \t\t                        <\/ul>\n\n\t                        \t                    <\/nav><!-- \/.nav-aside -->\n\t                <\/div><!-- \/.section__aside-nav -->\n\n\t                \t\t                <div class=\"section__aside-content\" data-aos=\"fade-right\">\n\t\t                \t<p>Together for total footcare.<\/p>\n\t\t                <\/div><!-- \/.section__aside-content -->\n\t                \t            <\/div><!-- \/.section__aside-group -->\n\t        <\/div><!-- \/.section__aside -->\n    \t\n        <div class=\"section__content section__content--secondary\" data-aos=\"fade-left\">\n            <div class=\"section__content-entry\">\n            \t\t                <h1>\n\t                \tRecht und Vorschriften\t                <\/h1>\n            \t<p>Gesetze und Vorschriften spielen in unserem Bereich eine immer gr\u00f6\u00dfere Rolle. Es ist ein wichtiges Thema, weshalb wir es f\u00fcr sehr wichtig halten, unsere Partner so gut und umfassend wie m\u00f6glich dar\u00fcber zu informieren.<\/p>\n            <\/div><!-- \/.section__content-entry -->\n\n                    <\/div><!-- \/.section__content -->\n\n\t\t\t\t\t<div class=\"section__video--secondary\" >\n\t\t\t\t\t\t\t\t\t<div class=\"section__box\" style=\"background-color: #f0be8c;\"><\/div><!-- \/.section__box -->\n\n\t\t\t\t\t<div class=\"section__figure\">\n\t\t\t\t\t\t<video width=\"\" autoplay muted playsinline loop>\n\t\t\t\t\t\t\t<source src=\"https:\/\/pltproducts.nl\/wp-content\/uploads\/sites\/8\/2023\/04\/WetEnRegelgeving_HeaderVideo2_V1.mp4\" type=\"video\/mp4\">\n\t\t\t\t\t\t<\/video>\n\t\t\t\t\t<\/div><!-- \/.section__figure -->\n\n\t\t\t\t\t<div class=\"section__box\" style=\"background-color: #f0be8c\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"64\" height=\"64\" src=\"https:\/\/pltproducts.nl\/wp-content\/uploads\/sites\/8\/2026\/08\/ico-logo-stepp.png\" class=\"attachment-app_full_width size-app_full_width\" alt=\"\" srcset=\"https:\/\/pltproducts.nl\/wp-content\/uploads\/sites\/8\/2026\/08\/ico-logo-stepp.png 64w, https:\/\/pltproducts.nl\/wp-content\/uploads\/sites\/8\/2026\/08\/ico-logo-stepp-12x12.png 12w, https:\/\/pltproducts.nl\/wp-content\/uploads\/sites\/8\/2026\/08\/ico-logo-stepp-30x30.png 30w, https:\/\/pltproducts.nl\/wp-content\/uploads\/sites\/8\/2026\/08\/ico-logo-stepp-27x27.png 27w\" sizes=\"auto, (max-width: 64px) 100vw, 64px\" \/>\n\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"64\" height=\"64\" src=\"https:\/\/pltproducts.nl\/wp-content\/uploads\/sites\/8\/2026\/08\/ico-logo-stepp.png\" class=\"attachment-app_full_width size-app_full_width\" alt=\"\" srcset=\"https:\/\/pltproducts.nl\/wp-content\/uploads\/sites\/8\/2026\/08\/ico-logo-stepp.png 64w, https:\/\/pltproducts.nl\/wp-content\/uploads\/sites\/8\/2026\/08\/ico-logo-stepp-12x12.png 12w, https:\/\/pltproducts.nl\/wp-content\/uploads\/sites\/8\/2026\/08\/ico-logo-stepp-30x30.png 30w, https:\/\/pltproducts.nl\/wp-content\/uploads\/sites\/8\/2026\/08\/ico-logo-stepp-27x27.png 27w\" sizes=\"auto, (max-width: 64px) 100vw, 64px\" \/>\t\t\t\t\t\t\t\t\t\t\t<\/div><!-- \/.section__box -->\n\t\t\t\t\t\t\t\t\t<div class=\"section__video-title\">\n\t\t\t\t\t\t<p>\n\t\t\t\t\t\t\tRecht und Vorschriften\t\t\t\t\t\t<\/p>\n\t\t\t\t\t<\/div><!-- \/.section__video-title -->\n\t\t\t\t\t\t\n\t\t\t<\/div><!-- \/.section__video-secondary -->\n\t\t    <\/div><!-- \/.shell -->\n<\/section><!-- \/.section-intro -->\n\n<section \n\tclass=\"section-content\" \n\tdata-background=\"none\" \n\tdata-id=\"section-02\" \n\tstyle=\"\"\n>\n\t\t\n\t\n    <div class=\"shell\">\n    \t\t        <div class=\"section__image image-fit\" data-aos=\"fade-up\">\n\t        \t<img loading=\"lazy\" decoding=\"async\" width=\"589\" height=\"284\" src=\"https:\/\/pltproducts.nl\/wp-content\/uploads\/sites\/8\/2023\/04\/WetEnRegelgevingFoto2.png\" class=\"attachment-app_full_width size-app_full_width\" alt=\"Recht und Regulierung Foto\" srcset=\"https:\/\/pltproducts.nl\/wp-content\/uploads\/sites\/8\/2023\/04\/WetEnRegelgevingFoto2.png 589w, https:\/\/pltproducts.nl\/wp-content\/uploads\/sites\/8\/2023\/04\/WetEnRegelgevingFoto2-300x145.png 300w, https:\/\/pltproducts.nl\/wp-content\/uploads\/sites\/8\/2023\/04\/WetEnRegelgevingFoto2-166x80.png 166w\" sizes=\"auto, (max-width: 589px) 100vw, 589px\" \/>\t        <\/div><!-- \/.section__image -->\n\t    \n        \t        <div class=\"section__body\" data-aos=\"fade-up\">\n\t            <div class=\"post\">\n\t                <div class=\"post__entry\">\n\t\t\t            \t\t\t\t            <h2>\n\t\t\t\t            \tMDR Rechtsvorschriften f\u00fcr Medizinprodukte\t\t\t\t            <\/h2>\n\t\t\t            <p>Bei PLT sind wir uns der geltenden Gesetze und Vorschriften bewusst. Bei der Entwicklung unserer Produkte und Dienstleistungen ziehen sich Gesetze und Vorschriften wie ein \"roter Faden\" durch unseren Prozess. So steht die (Patienten-)Sicherheit (einschlie\u00dflich MDR) unserer ma\u00dfgeschneiderten Produkte an erster Stelle und dies geht Hand in Hand mit der Benutzerfreundlichkeit f\u00fcr den Endverbraucher.<\/p>\n<p>Wir spielen eine Rolle bei der Bereitstellung von Hard- und Software in Verbindung mit dem Herstellungsprozess von kundenspezifischen Produkten. Wir sind f\u00fcr diese Prozesse verantwortlich. Wir versorgen die Organisation mit Dokumentation und Richtlinien, die f\u00fcr die MDR-Gesetze und -Vorschriften relevant sind.<\/p>\n\t                <\/div><!-- \/.post__entry -->\n\t            <\/div><!-- \/.post -->\n\t        <\/div><!-- \/.section__body -->\n            <\/div><!-- \/.shell -->\n<\/section><!-- \/.section-content -->\n\n\n<section \n\tclass=\"section-content  section-content--without-media\" \n\tdata-background=\"none\" \n\tdata-id=\"section-03\" \n\tstyle=\"\"\n>\n\t\t\n\t\n    <div class=\"shell\">\n    \t\n        \t        <div class=\"section__body\" data-aos=\"fade-up\">\n\t            <div class=\"post\">\n\t                <div class=\"post__entry\">\n\t\t\t            \t\t\t\t            <h2>\n\t\t\t\t            \tISO 13485 zertifiziert\t\t\t\t            <\/h2>\n\t\t\t            <p>Bei PLT Products stehen Qualit\u00e4t und Sicherheit an erster Stelle. Unser Qualit\u00e4tsmanagementsystem entspricht der internationalen ISO 13485-Zertifizierung - der Norm f\u00fcr Hersteller und Lieferanten von Medizinprodukten. Diese Zertifizierung stellt sicher, dass unsere Produkte und Prozesse den h\u00f6chsten Anforderungen an Regulierung, Zuverl\u00e4ssigkeit und Kundenzufriedenheit entsprechen. Indem wir nach ISO 13485 arbeiten, stellen wir sicher, dass unsere Medizinprodukte sicher in der Anwendung sind und dass die Risiken f\u00fcr die Patienten minimiert werden.<\/p>\n\t                <\/div><!-- \/.post__entry -->\n\t            <\/div><!-- \/.post -->\n\t        <\/div><!-- \/.section__body -->\n            <\/div><!-- \/.shell -->\n<\/section><!-- \/.section-content -->\n\n\n\n<section class=\"section-callout section-callout--gradient section-callout--global-color\" data-id=\"section-06\" style=\"\">\n\t<div class=\"shell\" data-aos=\"fade-up\">\n\t\t\n\t\t\t\t\t<div class=\"section__title\">\n\t\t\t\t<h6>\n\t\t\t\t\tArbeiten wir zusammen? Kontaktieren Sie uns unverbindlich.\t\t\t\t<\/h6>\n\t\t\t<\/div><!-- \/.section__title -->\n\t\t\t\t\t<div class=\"section__actions\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"\/de\/kontakt\/\" class=\"btn btn--color-secondary btn--flex\" target=\"\">\n\t\t\t\t\t\t\t<span>\n\t\t\t\t\t\t\t\tKontakt aufnehmen\t\t\t\t\t\t\t<\/span>\n\n\t\t\t\t\t\t\t<i class=\"ico-arrow-alt\">\n\t\t\t\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 15.52 7.34\">\n  <path d=\"M15.52,3.79l-3.55,3.55-.71-.7,2.36-2.35H0v-1h13.66l-2.4-2.58.71-.71,3.55,3.79Z\" \/>\n<\/svg>\t\t\t\t\t\t\t<\/i>\n\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t<a href=\"tel:0535740670\" class=\"btn btn--color-white btn--flex\" target=\"\">\n\t\t\t\t\t\t<span>\n\t\t\t\t\t\t\tRufen Sie uns an.\t\t\t\t\t\t<\/span>\n\n\t\t\t\t\t\t<i class=\"ico-arrow-alt\">\n\t\t\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" viewbox=\"0 0 15.52 7.34\">\n  <path d=\"M15.52,3.79l-3.55,3.55-.71-.7,2.36-2.35H0v-1h13.66l-2.4-2.58.71-.71,3.55,3.79Z\" \/>\n<\/svg>\t\t\t\t\t\t<\/i>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div><!-- \/.section__actions -->\n\t\t\t<\/div><!-- \/.shell -->\n<\/section><!-- \/.section-callout -->","protected":false},"excerpt":{"rendered":"","protected":false},"author":13,"featured_media":0,"parent":2611,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-2621","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Wet en Regelgeving | PLT Products<\/title>\n<meta name=\"description\" content=\"Bij het ontwikkelen van onze producten en diensten loopt Wet- en Regelgeving als een &#039;rode draad&#039; door ons proces. 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