{"id":19965,"date":"2021-09-02T13:55:07","date_gmt":"2021-09-02T20:55:07","guid":{"rendered":"https:\/\/www.arenasolutions.com\/designkontrollen-loesungen\/"},"modified":"2026-04-09T08:50:45","modified_gmt":"2026-04-09T15:50:45","slug":"designkontrollen-loesungen","status":"publish","type":"page","link":"https:\/\/www.arenasolutions.com\/de\/solutions\/design-controls\/","title":{"rendered":"Designkontrollen (L\u00f6sungen)"},"content":{"rendered":"

[et_pb_section fb_built=“1″ admin_label=“Hero-Text“ module_class=“as-db-hero-tier-3″ _builder_version=“4.27.5″ _module_preset=“default“ background_color=“#FFFFFF“ use_background_color_gradient=“on“ background_color_gradient_stops=“#ffffff 50%|rgba(61,70,71,0.15) 100%“ background_color_gradient_overlays_image=“on“ background_color_gradient_start=“rgba(27,31,37,0.3)“ background_color_gradient_end=“#1b1f25″ background_enable_image=“off“ custom_padding=“||31px|||“ locked=“off“ global_colors_info=“{}“][et_pb_row _builder_version=“4.27.5″ _module_preset=“default“ custom_padding=“0px||0px||false|false“ hover_enabled=“0″ global_colors_info=“{}“ custom_margin=“||70px||false|false“ sticky_enabled=“0″][et_pb_column type=“4_4″ _builder_version=“4.27.5″ _module_preset=“default“ global_colors_info=“{}“][et_pb_text admin_label=“Title“ _builder_version=“4.27.5″ _module_preset=“default“ header_text_align=“left“ header_font_size=“80px“ header_letter_spacing=“1px“ header_line_height=“1.1em“ header_2_letter_spacing=“1px“ header_2_line_height=“1.1em“ custom_margin=“2px||13px||false|false“ header_text_align_tablet=“center“ header_text_align_phone=“center“ header_text_align_last_edited=“on|phone“ header_font_size_tablet=“55px“ header_font_size_phone=“30px“ header_font_size_last_edited=“on|phone“ locked=“off“ global_colors_info=“{}“]<\/p>\n

Designkontrollen <\/h1>\n

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F\u00f6rdern von konformen
Produktdesignkontrollen <\/h4>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=“1_2,1_2″ use_custom_gutter=“on“ gutter_width=“2″ make_equal=“on“ disabled_on=“off|off|off“ module_class=“left-right-blurbs-row“ _builder_version=“4.27.5″ _module_preset=“default“ custom_padding=“50px||0px||false|false“ locked=“off“ global_colors_info=“{}“][et_pb_column type=“1_2″ _builder_version=“4.25.1″ _module_preset=“default“ hover_enabled=“0″ custom_css_main_element=“display: grid;||align-content: center;||“ global_colors_info=“{}“ sticky_enabled=“0″][et_pb_image src=“https:\/\/www.arenasolutions.com\/wp-content\/uploads\/FDA-Design-Dev-Process-Flow-DE.png“ alt=“Diagramm zu wichtigen Elementen von Designkontrollen“ title_text=“FDA-Design-Dev-Process-Flow“ _builder_version=“4.27.5″ max_width=“600px“ hover_enabled=“0″ locked=“off“ global_colors_info=“{}“ sticky_enabled=“0″][\/et_pb_image][\/et_pb_column][et_pb_column type=“1_2″ _builder_version=“4.27.5″ _module_preset=“default“ custom_css_main_element=“display: grid;||align-content: center;||“ global_colors_info=“{}“][et_pb_text content_tablet=“<\/p>\n

Gain Market Advantage With Compliant Product Development<\/h2>\n

The aerospace and defense market demands quality, product development efficiency, technological innovation, and regulatory compliance.<\/p>\n

Arena PLM for AWS GovCloud is the proven cloud product development solution for regulated companies requiring a secure platform to manage their product and quality information and meet regulatory requirements.<\/p>\n

“ content_phone=“<\/p>\n

Gain Market Advantage With Compliant Product Development<\/h2>\n

The aerospace and defense market demands quality, product development efficiency, technological innovation, and regulatory compliance.<\/p>\n

Arena PLM for AWS GovCloud is the proven cloud product development solution for regulated companies requiring a secure platform to manage their product and quality information and meet regulatory requirements.<\/p>\n

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Medizinprodukt-Unternehmen und ihre Lieferketten sind st\u00e4rker verstreut denn je. Alle, die an der Entwicklung und Einf\u00fchrung neuer Produkte beteiligt sind, m\u00fcssen die neuesten Produkt- und Qualit\u00e4tsinformationen teilen, pr\u00fcfen und verwenden, um sicherzustellen, dass wie geplant sichere und effektive Produkte hergestellt werden k\u00f6nnen. Und alle Prozesse m\u00fcssen mit den Vorgaben der US-Aufsichtsbeh\u00f6rde FDA und anderer Regulierungsgremien konform sein. <\/span><\/p>\n

Arena verwaltet die Kernelemente von Designkontrollen<\/a> und beschleunigt gleichzeitig die Innovation. Ihre Qualit\u00e4ts-, Technik- und Betriebsteams k\u00f6nnen schnell konforme Verfahren entwickeln, dokumentieren und einhalten.<\/span><\/p>\n

[\/et_pb_text][et_pb_button button_url=“\/white-papers\/strong-design-controls\/“ url_new_window=“on“ button_text=“Mehr erfahren“ button_alignment=“left“ button_alignment_tablet=“center“ button_alignment_phone=“center“ button_alignment_last_edited=“on|phone“ _builder_version=“4.27.5″ _module_preset=“67e2fde8-ec43-47ca-aa81-f27e635671cb“ custom_margin=“0px||||false|false“ locked=“off“ global_colors_info=“{}“][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=“1″ admin_label=“EXPLORE ARENA’S COMPREHENSIVE PLM PLATFORM“ _builder_version=“4.16″ background_color=“#FFFFFF“ use_background_color_gradient=“on“ background_color_gradient_stops=“#ffffff 50%|rgba(61,70,71,0.15) 100%“ background_color_gradient_overlays_image=“on“ background_color_gradient_start=“rgba(27,31,37,0.3)“ background_color_gradient_end=“#1b1f25″ background_enable_image=“off“ custom_padding=“100px||30px|||“ top_divider_style=“arrow“ top_divider_color=“rgba(61,70,71,0.15)“ global_colors_info=“{}“][et_pb_row _builder_version=“4.16″ custom_padding=“||0px|||“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“4.16″ global_colors_info=“{}“][et_pb_text _builder_version=“4.27.5″ text_text_color=“#FFFFFF“ header_2_text_align=“center“ header_2_text_color=“#000000″ text_orientation=“center“ custom_margin=“||0px|||“ global_colors_info=“{}“]<\/p>\n

Effektive Designkontrollen sorgen f\u00fcr mehr Audit-Vertrauen<\/h2>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=“4.16″ custom_padding=“16px||32px|||“ custom_css_main_element=“max-width: 1100px !important;“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“4.16″ global_colors_info=“{}“][et_pb_text _builder_version=“4.27.5″ text_orientation=“center“ module_alignment=“center“ global_colors_info=“{}“]<\/p>\n

Bei der Entwicklung von Medizinprodukten m\u00fcssen die Auflagen von FDA, EMA, ISO und andere Vorgaben eingehalten werden. <\/span>Durch die Designkontroll-Funktionen von Arena werden Ihre Pr\u00fcf-, Verfizierungs- und Validierungsprozesse vereinfacht. Arena QMS<\/a> beschleunigt Design\u00e4nderungen und -\u00fcbertragungen durch Festlegen und Verfolgen von Designkontroll-Elementen: Benutzerbedarf, Design-Inputs, Designprozesse, Design-Outputs und Produktdokumentation. <\/span><\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=“1_3,1_3,1_3″ use_custom_gutter=“on“ gutter_width=“2″ make_equal=“on“ module_class=“five-column-boxes white-boxes-row“ _builder_version=“4.16″ max_width=“1200px“ module_alignment=“center“ custom_padding=“0px||35px||false|false“ custom_css_main_element=“max-width: 990px !important;“ locked=“off“ global_colors_info=“{}“][et_pb_column type=“1_3″ _builder_version=“4.16″ global_colors_info=“{}“][et_pb_blurb image=“https:\/\/www.arenasolutions.com\/wp-content\/uploads\/Icon-QUALITY-TEAMS.svg“ alt=“quality teams icon“ image_icon_width=“40%“ _builder_version=“4.27.5″ header_level=“h3″ header_font=“|700|||||||“ header_text_align=“center“ header_text_color=“#3d4647″ background_color=“#FFFFFF“ text_orientation=“center“ height=“100%“ custom_padding=“30px|20px|30px|20px|true|true“ border_radii=“on|20px|20px|20px|20px“ border_width_all=“1px“ global_colors_info=“{}“]<\/p>\n

QUALIT\u00c4TS-
TEAMS<\/span><\/h4>\n

Verkn\u00fcpfen Sie CAPA-Prozesse mit dem Produktdatensatz, um die Qualit\u00e4t-Produkt-Schleife zu schlie\u00dfen<\/p>\n

[\/et_pb_blurb][\/et_pb_column][et_pb_column type=“1_3″ _builder_version=“4.16″ global_colors_info=“{}“][et_pb_blurb image=“https:\/\/www.arenasolutions.com\/wp-content\/uploads\/Icon-Change-Analysts.svg“ alt=“Icon-Change-Analysts“ image_icon_width=“40%“ _builder_version=“4.27.5″ header_level=“h3″ header_font=“|700|||||||“ header_text_align=“center“ header_text_color=“#3d4647″ background_color=“#FFFFFF“ text_orientation=“center“ height=“100%“ custom_padding=“30px|20px|30px|20px|true|true“ border_radii=“on|20px|20px|20px|20px“ border_width_all=“1px“ global_colors_info=“{}“]<\/p>\n

TEAMS ZUR EINHALTUNG REGULATORISCHER VORSCHRIFTEN<\/span><\/h4>\n

demonstrieren, dass Designkontroll-Prozesse festgelegt wurden und eingehalten werden <\/p>\n

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DESIGN-<\/span>
TEAMS<\/span><\/h4>\n

erstellen, \u00e4ndern und teilen die neuesten Design-Inputs zur Pr\u00fcfung, Verifizierung und Validierung<\/p>\n

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SYSTEME
TECHNIK-TEAMS<\/span><\/h4>\n

verwaltet dynamischen Benutzerbedarf als Anforderungen und verkn\u00fcpft diese mit Design-Inputs und Outputs<\/p>\n

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LIEFERKETTENPARTNER<\/span><\/h4>\n

setzen rollenbasierte Kontrollen ein, um Produktfreigaben und -\u00e4nderungen unter Wahrung der Sicherheit zu pr\u00fcfen und genehmigen<\/p>\n

[\/et_pb_blurb][\/et_pb_column][et_pb_column type=“1_3″ _builder_version=“4.16″ global_colors_info=“{}“][et_pb_blurb image=“https:\/\/www.arenasolutions.com\/wp-content\/uploads\/Icon-PROCUREMENT-TEAMS.svg“ alt=“Icon-PROCUREMENT TEAMS“ image_icon_width=“40%“ _builder_version=“4.27.5″ header_level=“h3″ header_font=“|700|||||||“ header_text_align=“center“ header_text_color=“#3d4647″ background_color=“#FFFFFF“ text_orientation=“center“ height=“100%“ custom_padding=“30px|20px|30px|20px|true|true“ border_radii=“on|20px|20px|20px|20px“ border_width_all=“1px“ global_colors_info=“{}“]<\/p>\n

BETRIEBS-
TEAMS<\/span><\/h4>\n

pr\u00fcfen und analysieren die vorgeschlagenen Produktentw\u00fcrfe auf ein fertigungsgerechtes Design <\/p>\n

[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=“1″ _builder_version=“4.16″ background_color=“#FFFFFF“ use_background_color_gradient=“on“ background_color_gradient_stops=“#ffffff 50%|rgba(61,70,71,0.15) 100%“ background_color_gradient_overlays_image=“on“ background_color_gradient_start=“rgba(27,31,37,0.3)“ background_color_gradient_end=“#1b1f25″ background_enable_image=“off“ custom_padding=“100px||5px|||“ top_divider_style=“arrow“ top_divider_color=“rgba(61,70,71,0.15)“ global_colors_info=“{}“][et_pb_row _builder_version=“4.16″ custom_padding=“51px||15px|||“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“4.16″ global_colors_info=“{}“][et_pb_text admin_label=“H2″ _builder_version=“4.27.5″ header_2_text_align=“center“ custom_margin=“||17px|||“ global_colors_info=“{}“]<\/p>\n

Eliminieren Sie manuelle Prozesse und isolierte, unverbundene Kalkulationstabellen<\/h2>\n

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Arena optimiert das Artikel- und St\u00fccklistenmanagement, um das Design und die Lieferung innovativer Produkte zu beschleunigen.<\/span><\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=“1_3,1_3,1_3″ _builder_version=“4.27.4″ _module_preset=“41dffb06-5c20-4d40-9217-99f1a757f6bd“ custom_padding=“20px||32px|||“ locked=“off“ global_colors_info=“{}“][et_pb_column type=“1_3″ _builder_version=“4.27.4″ _module_preset=“default“ custom_padding=“||||false|false“ custom_padding_tablet=“||||false|false“ custom_padding_phone=“||30px||false|false“ custom_padding_last_edited=“on|phone“ global_colors_info=“{}“][et_pb_blurb image=“https:\/\/www.arenasolutions.com\/wp-content\/uploads\/Ensures-Regulatory-Compliance.jpg“ alt=“Image-Compliance concept on a laptop screen“ _builder_version=“4.27.5″ header_level=“h3″ header_font=“|700||on|||||“ header_text_align=“center“ header_text_color=“#00890B“ header_font_size=“20px“ header_line_height=“1.2em“ body_font=“|700||on|||||“ body_text_align=“center“ body_text_color=“#3D4647″ body_font_size=“26px“ body_line_height=“1.2em“ locked=“off“ global_colors_info=“{}“]<\/p>\n

Kein Stress mit Audits<\/p>\n

[\/et_pb_blurb][et_pb_toggle title=“Wie Arena Ihnen hilft“ icon_color=“#00890B“ open_icon_color=“#3D4647″ _builder_version=“4.27.5″ title_text_color=“#3D4647″ title_level=“h3″ title_font=“|||on|||||“ title_font_size=“18px“ title_letter_spacing=“1px“ closed_title_font_size=“18px“ closed_title_letter_spacing=“1px“ body_line_height=“1.3em“ background_color=“#FFFFFF“ custom_margin=“0px||0px||false|false“ custom_padding=“10px||10px||false|false“ border_color_all=“#c5c6cb“ global_colors_info=“{}“]<\/p>\n

    \n
  • Arena erm\u00f6glicht Designkontrolle-Compliance<\/span><\/li>\n
  • Pr\u00fcfer k\u00f6nnen leicht Nachweise finden, dass konforme Prozesse festgelegt, dokumentiert und eingehalten werden
    <\/span><\/li>\n<\/ul>\n

    [\/et_pb_toggle][\/et_pb_column][et_pb_column type=“1_3″ _builder_version=“4.27.4″ _module_preset=“default“ custom_padding_tablet=““ custom_padding_phone=“||30px||false|false“ custom_padding_last_edited=“on|phone“ global_colors_info=“{}“][et_pb_blurb image=“https:\/\/www.arenasolutions.com\/wp-content\/uploads\/Reduces-Confusion-Mistakes.jpg“ alt=“Image-Conceptual image of a folder with a keyhole integrated on a circuit board, suggesting data protection & information security“ _builder_version=“4.27.5″ header_level=“h3″ header_font=“|700||on|||||“ header_text_align=“center“ header_text_color=“#00890B“ header_font_size=“20px“ header_line_height=“1.2em“ body_font=“|700||on|||||“ body_text_align=“center“ body_text_color=“#3D4647″ body_font_size=“26px“ body_line_height=“1.2em“ custom_padding=“||0px|||“ locked=“off“ global_colors_info=“{}“]<\/p>\n

    Weniger Verwirrung
    und Fehler<\/p>\n

    [\/et_pb_blurb][et_pb_toggle title=“Wie Arena Ihnen hilft“ icon_color=“#00890B“ open_icon_color=“#3D4647″ _builder_version=“4.27.5″ title_text_color=“#3D4647″ title_level=“h3″ title_font=“|||on|||||“ title_font_size=“18px“ title_letter_spacing=“1px“ closed_title_font_size=“18px“ closed_title_letter_spacing=“1px“ body_line_height=“1.3em“ background_color=“#FFFFFF“ custom_margin=“0px||0px||false|false“ custom_padding=“10px||10px||false|false“ border_color_all=“#c5c6cb“ global_colors_info=“{}“]<\/p>\n

      \n
    • Wenn Qualit\u00e4t und Design miteinander verbunden werden, weitet sich das auf die gesamte Lieferkette aus und reduziert die mit weit verteilten Teams verbundenen Herausforderungen
      <\/span><\/li>\n
    • Durch die Zentralisierung von St\u00fccklisten, DHF und DMR mit den zugeordneten Produktdesign- und Qualit\u00e4tsdatens\u00e4tzen arbeiten immer alle auf der gleichen Informationsgrundlage
      <\/span><\/li>\n<\/ul>\n

      [\/et_pb_toggle][\/et_pb_column][et_pb_column type=“1_3″ _builder_version=“4.27.4″ _module_preset=“default“ global_colors_info=“{}“][et_pb_blurb image=“https:\/\/www.arenasolutions.com\/wp-content\/uploads\/Control-Access-Design.jpg“ alt=“Image-Abstract network grid with files and folders, futuristic software interface, digital document management system, store, search and organize documents“ _builder_version=“4.27.5″ header_level=“h3″ header_font=“|700||on|||||“ header_text_align=“center“ header_text_color=“#00890B“ header_font_size=“20px“ header_line_height=“1.2em“ body_font=“|700||on|||||“ body_text_align=“center“ body_text_color=“#3D4647″ body_font_size=“26px“ body_line_height=“1.2em“ locked=“off“ global_colors_info=“{}“]<\/p>\n

      Kontrollierter Zugriff auf
      Ihr gesamtes Design<\/p>\n

      [\/et_pb_blurb][et_pb_toggle title=“Wie Arena Ihnen hilft“ icon_color=“#00890B“ open_icon_color=“#3D4647″ _builder_version=“4.27.5″ title_text_color=“#3D4647″ title_level=“h3″ title_font=“|||on|||||“ title_font_size=“18px“ title_letter_spacing=“1px“ closed_title_font_size=“18px“ closed_title_letter_spacing=“1px“ body_line_height=“1.3em“ background_color=“#FFFFFF“ custom_margin=“0px||0px||false|false“ custom_padding=“10px||10px||false|false“ border_color_all=“#c5c6cb“ global_colors_info=“{}“]<\/p>\n

        \n
      • Artikel- und St\u00fccklisten-Informationen mit Revisionskontrolle sind mit den jeweiligen Konstruktions\u00e4nderungen, Qualit\u00e4tsma\u00dfnahmen, Herstellern und Lieferanten verkn\u00fcpft
        <\/span><\/li>\n
      • Erstellung, \u00c4nderung und sichere Freigabe von Produktdesigns f\u00fcr Qualit\u00e4tsteams, Betriebsteams und Lieferanten, um eine funktions\u00fcbergreifende Pr\u00fcfung zu erm\u00f6glichen
        <\/span><\/li>\n<\/ul>\n

        [\/et_pb_toggle][\/et_pb_column][\/et_pb_row][et_pb_row module_class=“locale-hide-cn “ _builder_version=“4.22.0″ custom_padding=“29px||4px|||“ locked=“off“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“4.16″ global_colors_info=“{}“][et_pb_text _builder_version=“4.27.5″ text_orientation=“center“ custom_margin=“||30px||false|false“ global_colors_info=“{}“]<\/p>\n

        Erfahren Sie, wie leistungsstarke Designkontrollen die Compliance vereinfachen und Audit-Sorgen ausr\u00e4umen.<\/span><\/p>\n

        [\/et_pb_text][et_pb_button button_url=“\/white-papers\/strong-design-controls\/“ button_text=“Whitepaper lesen“ button_alignment=“center“ _builder_version=“4.27.5″ _module_preset=“67e2fde8-ec43-47ca-aa81-f27e635671cb“ global_colors_info=“{}“][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=“1″ _builder_version=“4.16″ background_color=“#FFFFFF“ use_background_color_gradient=“on“ background_color_gradient_stops=“#ffffff 50%|rgba(61,70,71,0.15) 100%“ background_color_gradient_overlays_image=“on“ background_color_gradient_start=“rgba(27,31,37,0.3)“ background_color_gradient_end=“#1b1f25″ background_enable_image=“off“ custom_padding=“100px||30px|||“ top_divider_style=“arrow“ top_divider_color=“rgba(61,70,71,0.15)“ global_colors_info=“{}“][et_pb_row column_structure=“1_2,1_2″ use_custom_gutter=“on“ gutter_width=“4″ make_equal=“on“ _builder_version=“4.16″ custom_margin=“||50px||false|false“ global_colors_info=“{}“][et_pb_column type=“1_2″ _builder_version=“4.16″ global_colors_info=“{}“][et_pb_image src=“https:\/\/www.arenasolutions.com\/wp-content\/uploads\/Webinar-Establish-Compliant-Design-Controls.jpg“ alt=“Bild \u2013 Erster Frame des Videos, das die PowerPoint-Folie mit diesem Titel anzeigt: Erfolgsrezepte von Qualit\u00e4tsbeauftragten f\u00fcr die Designkontrolle von Medizinprodukten“ title_text=“Webinar \u2013 Konforme Designkontrollen festlegen“ _builder_version=“4.27.5″ border_radii=“on|20px|20px|20px|20px“ border_width_all=“1px“ border_color_all=“#617480″ global_colors_info=“{}“][\/et_pb_image][\/et_pb_column][et_pb_column type=“1_2″ _builder_version=“4.16″ custom_css_main_element=“display: grid;||align-content: center;“ global_colors_info=“{}“][et_pb_text _builder_version=“4.27.5″ header_4_text_align=“left“ custom_margin=“||30px||false|false“ header_4_text_align_tablet=“right“ header_4_text_align_phone=““ header_4_text_align_last_edited=“on|tablet“ text_orientation_tablet=“right“ text_orientation_phone=“left“ text_orientation_last_edited=“on|tablet“ global_colors_info=“{}“]<\/p>\n

        Medizinprodukt-Unternehmen wissen, dass effektive Designkontrollen zu qualitativ hochwertigen Produkten f\u00fchren. Mit Arena k\u00f6nnen Ihre Produktteams konforme Designkontrollen erstellen, dokumentieren und einhalten. Dies erm\u00f6glicht eine teamweite Transparenz f\u00fcr alle Ihre Produkt- und Qualit\u00e4tsdatens\u00e4tze. Arena QMS bietet die erforderlichen Designkontrollen, damit Sie schnell innovative, konforme Medizinprodukte liefern k\u00f6nnen. <\/span><\/p>\n

        [\/et_pb_text][et_pb_button button_url=“\/resources\/plm-webinars\/quality-experts-share-keys-to-medical-device-design-controls-success\/“ button_text=“Webinar ansehen“ module_class=“locale-hide-cn“ _builder_version=“4.27.5″ _module_preset=“67e2fde8-ec43-47ca-aa81-f27e635671cb“ global_colors_info=“{}“][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=“1″ admin_label=“Quote“ module_class=“quote-section“ _builder_version=“4.18.0″ background_image=“https:\/\/www.arenasolutions.com\/wp-content\/uploads\/dark-purple-background.jpg“ custom_padding=“19px||19px||true|“ global_colors_info=“{}“][et_pb_row use_custom_gutter=“on“ gutter_width=“1″ make_equal=“on“ _builder_version=“4.16″ custom_padding=“20px||20px||true|false“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“4.16″ custom_padding=“30px||30px|40px|true|false“ custom_padding_tablet=“|||0px|false|false“ custom_padding_phone=““ custom_padding_last_edited=“on|tablet“ custom_css_main_element=“display: grid;||align-content: center;“ global_colors_info=“{}“][et_pb_text _builder_version=“4.27.5″ text_text_color=“#FFFFFF“ text_font_size=“24px“ text_orientation=“center“ max_width=“985px“ module_alignment=“center“ global_colors_info=“{}“]<\/p>\n

        \u201eWir integrieren das Risikomanagement gem\u00e4\u00df 21 CFR Teil 820.30 in den gesamten Designkontroll-Prozess. Das Risikomanagement beginnt bereits fr\u00fch im Designprozess, wenn die Benutzeranforderungen und Design-Inputs definiert werden. Durch diese fr\u00fchzeitige Identifizierung der Risiken k\u00f6nnen wir erfolgreiche Designverifizierungs- und -validierungs-Ergebnisse liefern.\u201c<\/span><\/p>\n

        [\/et_pb_text][et_pb_text _builder_version=“4.27.5″ text_text_color=“#afb1ff“ text_orientation=“center“ custom_margin=“24px||||false|false“ global_colors_info=“{}“]<\/p>\n

        Vis Ayer  <\/strong>Senior Director, Nevro<\/span><\/p>\n

        [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=“1″ _builder_version=“4.27.5″ custom_padding=“30px||29px|||“ global_colors_info=“{}“][et_pb_row _builder_version=“4.16″ custom_padding=“29px|||||“ global_colors_info=“{}“][et_pb_column type=“4_4″ _builder_version=“4.16″ global_colors_info=“{}“][et_pb_text _builder_version=“4.27.5″ header_2_text_align=“center“ text_orientation=“center“ custom_margin=“||10px||false|false“ global_colors_info=“{}“]<\/p>\n

        Machen Sie es wie diese innovativen Kunden<\/h2>\n

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        Erleben Sie Arena
        in Aktion<\/h2>\n

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        Designkontrollen F\u00f6rdern von konformen Produktdesignkontrollen Medizinprodukt-Unternehmen und ihre Lieferketten sind st\u00e4rker verstreut denn je. Alle, die an der Entwicklung und Einf\u00fchrung neuer…<\/p>\n","protected":false},"author":55,"featured_media":24048,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"divi.php","meta":{"_acf_changed":false,"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"class_list":["post-19965","page","type-page","status-publish","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"\nDesignkontrollen f\u00fcr die Einhaltung regulatorischer Vorschriften | Arena<\/title>\n<meta name=\"description\" content=\"Medizinprodukt-Unternehmen wissen, dass effektive Designkontrollen erfolgreiche Produkteinf\u00fchrungen erm\u00f6glichen. Mit Arena k\u00f6nnen Ihre Produktteams konforme Designkontrollen erstellen, dokumentieren und einhalten. 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