{"id":20550,"date":"2021-09-24T07:41:52","date_gmt":"2021-09-24T14:41:52","guid":{"rendered":"https:\/\/www.arenasolutions.com\/?page_id=20550"},"modified":"2026-07-13T09:15:50","modified_gmt":"2026-07-13T16:15:50","slug":"medical-device-compliance","status":"publish","type":"page","link":"https:\/\/www.arenasolutions.com\/de\/solutions\/compliance-management\/medical-devices\/","title":{"rendered":"Compliance bei Medizinprodukten"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8220;1&#8243; admin_label=&#8220;Hero-Text&#8220; module_class=&#8220;as-db-hero-tier-3&#8243; _builder_version=&#8220;4.27.5&#8243; _module_preset=&#8220;default&#8220; background_color=&#8220;#FFFFFF&#8220; use_background_color_gradient=&#8220;on&#8220; background_color_gradient_stops=&#8220;#ffffff 50%|#e1e2e3 100%&#8220; background_color_gradient_overlays_image=&#8220;on&#8220; background_color_gradient_start=&#8220;rgba(27,31,37,0.3)&#8220; background_color_gradient_end=&#8220;#1b1f25&#8243; background_enable_image=&#8220;off&#8220; custom_padding=&#8220;||31px|||&#8220; locked=&#8220;off&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_row _builder_version=&#8220;4.27.5&#8243; _module_preset=&#8220;default&#8220; custom_padding=&#8220;4px||6px|||&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_column type=&#8220;4_4&#8243; _builder_version=&#8220;4.27.5&#8243; _module_preset=&#8220;default&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_text admin_label=&#8220;Title&#8220; _builder_version=&#8220;4.27.5&#8243; _module_preset=&#8220;default&#8220; header_text_align=&#8220;left&#8220; header_font_size=&#8220;80px&#8220; header_letter_spacing=&#8220;1px&#8220; header_line_height=&#8220;1.1em&#8220; header_2_letter_spacing=&#8220;1px&#8220; header_2_line_height=&#8220;1.1em&#8220; custom_margin=&#8220;2px||13px||false|false&#8220; header_text_align_tablet=&#8220;center&#8220; header_text_align_phone=&#8220;center&#8220; header_text_align_last_edited=&#8220;on|phone&#8220; header_font_size_tablet=&#8220;55px&#8220; header_font_size_phone=&#8220;30px&#8220; header_font_size_last_edited=&#8220;on|phone&#8220; locked=&#8220;off&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<h1>Medizinprodukt-Audit<\/h1>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8220;4.27.5&#8243; _module_preset=&#8220;default&#8220; text_font=&#8220;|600|||||||&#8220; text_text_color=&#8220;#00890b&#8220; text_letter_spacing=&#8220;1px&#8220; text_line_height=&#8220;1.5em&#8220; text_font_size_tablet=&#8220;30px&#8220; text_font_size_phone=&#8220;20px&#8220; text_font_size_last_edited=&#8220;on|phone&#8220; text_line_height_tablet=&#8220;1.4em&#8220; text_line_height_phone=&#8220;1.3em&#8220; text_line_height_last_edited=&#8220;on|desktop&#8220; text_orientation_tablet=&#8220;center&#8220; text_orientation_phone=&#8220;center&#8220; text_orientation_last_edited=&#8220;on|desktop&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<h3>Vereinfachen Sie die Compliance in Bezug auf FDA, EU MDR und ISO<\/h3>\n<p>\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8220;1&#8243; _builder_version=&#8220;4.16&#8243; background_color=&#8220;#FFFFFF&#8220; use_background_color_gradient=&#8220;on&#8220; background_color_gradient_stops=&#8220;#ffffff 50%|#e1e2e3 100%&#8220; background_color_gradient_overlays_image=&#8220;on&#8220; background_color_gradient_start=&#8220;rgba(27,31,37,0.3)&#8220; background_color_gradient_end=&#8220;#1b1f25&#8243; background_enable_image=&#8220;off&#8220; custom_margin=&#8220;0px||0px||false|false&#8220; custom_padding=&#8220;100px||0px||false|false&#8220; top_divider_style=&#8220;arrow&#8220; top_divider_color=&#8220;#e1e2e3&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_row _builder_version=&#8220;4.16&#8243; custom_padding=&#8220;||18px|||&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_column type=&#8220;4_4&#8243; _builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_text _builder_version=&#8220;4.27.5&#8243; header_2_text_align=&#8220;center&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<h2 class=\"dark-green\">Beschleunigen Sie die Vorschrifts- und Anforderungsbereitschaft<\/h2>\n<p>\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8220;1_2,1_2&#8243; use_custom_gutter=&#8220;on&#8220; gutter_width=&#8220;2&#8243; make_equal=&#8220;on&#8220; _builder_version=&#8220;4.27.5&#8243; custom_margin=&#8220;|auto|0px|auto|false|false&#8220; custom_padding=&#8220;4px||||false|false&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_column type=&#8220;1_2&#8243; _builder_version=&#8220;4.16&#8243; custom_css_main_element=&#8220;display: grid;&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_image src=&#8220;https:\/\/www.arenasolutions.com\/wp-content\/uploads\/Med-Dev-Patient-Safety.jpg&#8220; alt=&#8220;Bild\u00a0\u2013 Ein Stethoskop liegt zusammen mit einem medizinischen Schutzschild auf einer Leiterplatte vor technologischem Hintergrund und symbolisiert Datenschutz&#8220; title_text=&#8220;Medizintechnik\u00a0\u2013 Patientensicherheit&#8220; align=&#8220;center&#8220; _builder_version=&#8220;4.27.5&#8243; max_width=&#8220;575px&#8220; border_radii=&#8220;on|20px|20px|20px|20px&#8220; global_colors_info=&#8220;{}&#8220;][\/et_pb_image][\/et_pb_column][et_pb_column type=&#8220;1_2&#8243; _builder_version=&#8220;4.16&#8243; custom_css_main_element=&#8220;display: grid;||align-items: center;&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_text _builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;]<\/p>\n<p><span>Zur Gew\u00e4hrleistung der Patientensicherheit m\u00fcssen Hersteller von Medizinprodukten Qualit\u00e4tssysteme schaffen und unterhalten, die die Einhaltung regulatorischer Vorschriften in Bezug auf <a href=\"https:\/\/www.arenasolutions.com\/resources\/glossary\/fda-compliance\/\">FDA<\/a>, <a href=\"https:\/\/www.arenasolutions.com\/resources\/glossary\/european-union-medical-device-regulation\/\">EU MDR<\/a>, <a href=\"https:\/\/www.arenasolutions.com\/resources\/glossary\/iso\/\">ISO<\/a> und andere Aufsichtsbeh\u00f6rden sicherstellen. Ihr Vermarktungserfolg h\u00e4ngt entscheidend von Vorschriften wie der FDA 21 CFR Teil 820 und ISO 13485 ab.<\/span><\/p>\n\n<p><span>Arenas cloudbasierte QMS-Software hilft Ihnen, eine leistungsstarke <a href=\"https:\/\/www.arenasolutions.com\/de\/solutions\/design-controls\/\">Designkontrolle<\/a> zu gew\u00e4hrleisten und aufrechtzuerhalten. Dies vereinfacht die Verwaltung von Standardarbeitsanweisungen (SOP), Ger\u00e4teverlaufsdateien (DHF), Ger\u00e4testammdatens\u00e4tzen (DMR), Schulungsdatens\u00e4tzen und s\u00e4mtlicher Produktdatens\u00e4tze mithilfe der Verlinkung aller Qualit\u00e4ts- und Produktangaben w\u00e4hrend der Entwicklung und Einf\u00fchrung neuer Produkte.<\/span><\/p>\n<p>\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8220;1&#8243; admin_label=&#8220;EXPLORE ARENA&#8217;S COMPREHENSIVE PLM PLATFORM&#8220; _builder_version=&#8220;4.16&#8243; background_color=&#8220;#FFFFFF&#8220; use_background_color_gradient=&#8220;on&#8220; background_color_gradient_stops=&#8220;#ffffff 50%|#e1e2e3 100%&#8220; background_color_gradient_overlays_image=&#8220;on&#8220; background_color_gradient_start=&#8220;rgba(27,31,37,0.3)&#8220; background_color_gradient_end=&#8220;#1b1f25&#8243; background_enable_image=&#8220;off&#8220; custom_margin=&#8220;0px||0px||false|false&#8220; custom_padding=&#8220;100px||0px||false|false&#8220; top_divider_style=&#8220;arrow&#8220; top_divider_color=&#8220;#e1e2e3&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_row _builder_version=&#8220;4.16&#8243; custom_padding=&#8220;||0px|||&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_column type=&#8220;4_4&#8243; _builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_text _builder_version=&#8220;4.27.5&#8243; text_text_color=&#8220;#FFFFFF&#8220; header_2_text_align=&#8220;center&#8220; header_2_text_color=&#8220;#000000&#8243; text_orientation=&#8220;center&#8220; custom_margin=&#8220;||0px|||&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<h2 class=\"dark-green\" style=\"text-align: center;\">Cloud-QMS vereinfacht die regulatorische Compliance<\/h2>\n<p>\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=&#8220;4.16&#8243; custom_padding=&#8220;16px||32px|||&#8220; custom_css_main_element=&#8220;max-width: 1100px !important;&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_column type=&#8220;4_4&#8243; _builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_text _builder_version=&#8220;4.16&#8243; text_orientation=&#8220;center&#8220; module_alignment=&#8220;center&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<p><span>Die Markteinf\u00fchrung sicherer, konformer und <a href=\"https:\/\/www.arenasolutions.com\/de\/medical-device\/\">innovativer Medizinprodukte<\/a> ist keine einfache Aufgabe, denn dies erfordert die genaue Abstimmung zwischen Ihren Qualit\u00e4ts-, technischen und Betriebsteams sowie Ihren Lieferkettenpartnern.&nbsp;<\/span><span><a href=\"https:\/\/www.arenasolutions.com\/de\/platform\/qms\/\">Die Arena Quality Management System (QMS)<\/a> Software bietet Ihnen ein einzelnes System of Truth zur Produktentwicklung und -einf\u00fchrung sowie zur gleichzeitigen Eliminierung von Compliance-Risiken.<\/span><\/p>\n<p>\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8220;1_3,1_3,1_3&#8243; use_custom_gutter=&#8220;on&#8220; gutter_width=&#8220;2&#8243; make_equal=&#8220;on&#8220; module_class=&#8220;five-column-boxes white-boxes-row&#8220; _builder_version=&#8220;4.16&#8243; max_width=&#8220;1200px&#8220; module_alignment=&#8220;center&#8220; custom_padding=&#8220;0px||35px||false|false&#8220; custom_css_main_element=&#8220;max-width: 990px !important;&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_column type=&#8220;1_3&#8243; _builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_blurb image=&#8220;https:\/\/www.arenasolutions.com\/wp-content\/uploads\/Icon-QUALITY-TEAMS.svg&#8220; alt=&#8220;Quality Assurance icon&#8220; image_icon_width=&#8220;40%&#8220; _builder_version=&#8220;4.27.5&#8243; header_level=&#8220;h3&#8243; header_font=&#8220;|700|||||||&#8220; header_text_align=&#8220;center&#8220; header_text_color=&#8220;#3d4647&#8243; background_color=&#8220;#FFFFFF&#8220; text_orientation=&#8220;center&#8220; height=&#8220;100%&#8220; custom_padding=&#8220;30px|20px|30px|20px|true|true&#8220; hover_enabled=&#8220;0&#8243; border_radii=&#8220;on|20px|20px|20px|20px&#8220; border_width_all=&#8220;1px&#8220; global_colors_info=&#8220;{}&#8220; sticky_enabled=&#8220;0&#8243;]<\/p>\n<h4><span style=\"color: #00890b;\">QUALIT\u00c4TS-<\/span><br \/><span style=\"color: #00890b;\"> SICHERUNGSTEAMS<\/span><\/h4>\n\n<p>verfolgen Closed-Loop-<a href=\"https:\/\/www.arenasolutions.com\/de\/solutions\/quality-management\/\">Qualit\u00e4tsprozesse<\/a>, um die Nachverfolgbarkeit zu verbessern.<\/p>\n<p>\n[\/et_pb_blurb][\/et_pb_column][et_pb_column type=&#8220;1_3&#8243; _builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_blurb image=&#8220;https:\/\/www.arenasolutions.com\/wp-content\/uploads\/Icon-Change-Analysts.svg&#8220; alt=&#8220;Icon-Change-Analysts&#8220; image_icon_width=&#8220;40%&#8220; _builder_version=&#8220;4.27.5&#8243; header_level=&#8220;h3&#8243; header_font=&#8220;|700|||||||&#8220; header_text_align=&#8220;center&#8220; header_text_color=&#8220;#3d4647&#8243; background_color=&#8220;#FFFFFF&#8220; text_orientation=&#8220;center&#8220; height=&#8220;100%&#8220; custom_padding=&#8220;30px|20px|30px|20px|true|true&#8220; hover_enabled=&#8220;0&#8243; border_radii=&#8220;on|20px|20px|20px|20px&#8220; border_width_all=&#8220;1px&#8220; global_colors_info=&#8220;{}&#8220; sticky_enabled=&#8220;0&#8243;]<\/p>\n<h4><span style=\"color: #00890b;\">AUFSICHTS-BEH\u00d6RDLICHE<\/span><br \/><span style=\"color: #00890b;\">ANGELEGENHEITEN<\/span><\/h4>\n\n<p>sorgen f\u00fcr eine starke Designkontrolle und gew\u00e4hrleisten die Einhaltung regulatorischer Vorschriften<\/p>\n<p>\n[\/et_pb_blurb][\/et_pb_column][et_pb_column type=&#8220;1_3&#8243; _builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_blurb image=&#8220;https:\/\/www.arenasolutions.com\/wp-content\/uploads\/Icon-MGMT-Teams.svg&#8220; alt=&#8220;Icon-MGMT-Teams&#8220; image_icon_width=&#8220;40%&#8220; _builder_version=&#8220;4.27.5&#8243; header_level=&#8220;h3&#8243; header_font=&#8220;|700|||||||&#8220; header_text_align=&#8220;center&#8220; header_text_color=&#8220;#3d4647&#8243; background_color=&#8220;#FFFFFF&#8220; text_orientation=&#8220;center&#8220; height=&#8220;100%&#8220; custom_padding=&#8220;30px|20px|30px|20px|true|true&#8220; hover_enabled=&#8220;0&#8243; border_radii=&#8220;on|20px|20px|20px|20px&#8220; border_width_all=&#8220;1px&#8220; global_colors_info=&#8220;{}&#8220; sticky_enabled=&#8220;0&#8243;]<\/p>\n<h4><span style=\"color: #00890b;\">MANAGEMENT<\/span><br \/><span style=\"color: #00890b;\"> TEAMS<\/span><\/h4>\n\n<p>verbessern die Einhaltung von <a href=\"https:\/\/www.arenasolutions.com\/de\/solutions\/training-management\/\">Schulungsdatens\u00e4tzen,<\/a> SOP und mehr<\/p>\n<p>\n[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8220;1_3,1_3,1_3&#8243; use_custom_gutter=&#8220;on&#8220; gutter_width=&#8220;2&#8243; make_equal=&#8220;on&#8220; module_class=&#8220;five-column-boxes white-boxes-row&#8220; _builder_version=&#8220;4.16&#8243; max_width=&#8220;1200px&#8220; module_alignment=&#8220;center&#8220; custom_padding=&#8220;0px||35px||false|false&#8220; custom_css_main_element=&#8220;max-width: 990px !important;&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_column type=&#8220;1_3&#8243; _builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_blurb image=&#8220;https:\/\/www.arenasolutions.com\/wp-content\/uploads\/Icon-ENGINEERING-TEAMS.svg&#8220; alt=&#8220;engineering teams icon&#8220; image_icon_width=&#8220;40%&#8220; _builder_version=&#8220;4.27.5&#8243; header_level=&#8220;h3&#8243; header_font=&#8220;|700|||||||&#8220; header_text_align=&#8220;center&#8220; header_text_color=&#8220;#3d4647&#8243; background_color=&#8220;#FFFFFF&#8220; text_orientation=&#8220;center&#8220; height=&#8220;100%&#8220; custom_padding=&#8220;30px|20px|30px|20px|true|true&#8220; hover_enabled=&#8220;0&#8243; border_radii=&#8220;on|20px|20px|20px|20px&#8220; border_width_all=&#8220;1px&#8220; global_colors_info=&#8220;{}&#8220; sticky_enabled=&#8220;0&#8243;]<\/p>\n<h4><span style=\"color: #00890b;\">TECHNIK-<br \/>TEAMS<\/span><\/h4>\n\n<p><span>erhalten Einblicke zur kontinuierlichen Verbesserung konformer Designs&nbsp;<\/span><\/p>\n<p>\n[\/et_pb_blurb][\/et_pb_column][et_pb_column type=&#8220;1_3&#8243; _builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_blurb image=&#8220;https:\/\/www.arenasolutions.com\/wp-content\/uploads\/Icon-Doc-Mgmt.svg&#8220; alt=&#8220;Document Control icon&#8220; image_icon_width=&#8220;40%&#8220; _builder_version=&#8220;4.27.5&#8243; header_level=&#8220;h3&#8243; header_font=&#8220;|700|||||||&#8220; header_text_align=&#8220;center&#8220; header_text_color=&#8220;#3d4647&#8243; background_color=&#8220;#FFFFFF&#8220; text_orientation=&#8220;center&#8220; height=&#8220;100%&#8220; custom_padding=&#8220;30px|20px|30px|20px|true|true&#8220; hover_enabled=&#8220;0&#8243; border_radii=&#8220;on|20px|20px|20px|20px&#8220; border_width_all=&#8220;1px&#8220; global_colors_info=&#8220;{}&#8220; sticky_enabled=&#8220;0&#8243;]<\/p>\n<h4><span style=\"color: #00890b;\">DOKUMENTEN-<\/span><br \/><span style=\"color: #00890b;\">KONTROLLE<\/span><\/h4>\n\n<p>kann als Vorbereitung f\u00fcr sowie interne Abnahme von ISO-, EU-MDR- oder <a href=\"https:\/\/www.arenasolutions.com\/resources\/articles\/fda-audit-tips\/\">FDA-Audits<\/a> dienen<\/p>\n<p>\n[\/et_pb_blurb][\/et_pb_column][et_pb_column type=&#8220;1_3&#8243; _builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_blurb image=&#8220;https:\/\/www.arenasolutions.com\/wp-content\/uploads\/Icons-EXECUTIVE-MANAGEMENT.svg&#8220; alt=&#8220;Executive Icon&#8220; image_icon_width=&#8220;40%&#8220; _builder_version=&#8220;4.27.5&#8243; header_level=&#8220;h3&#8243; header_font=&#8220;|700|||||||&#8220; header_text_align=&#8220;center&#8220; header_text_color=&#8220;#3d4647&#8243; background_color=&#8220;#FFFFFF&#8220; text_orientation=&#8220;center&#8220; height=&#8220;100%&#8220; custom_padding=&#8220;30px|20px|30px|20px|true|true&#8220; hover_enabled=&#8220;0&#8243; border_radii=&#8220;on|20px|20px|20px|20px&#8220; border_width_all=&#8220;1px&#8220; global_colors_info=&#8220;{}&#8220; sticky_enabled=&#8220;0&#8243;]<\/p>\n<h4><span style=\"color: #00890b;\">GESCH\u00c4FTSF\u00dcHRUNGS-TEAMS<\/span><\/h4>\n\n<p>k\u00f6nnen bessere Entscheidungen f\u00fcr eine schnellere Vermarktung treffen<\/p>\n<p>\n[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8220;1&#8243; _builder_version=&#8220;4.16&#8243; background_color=&#8220;#FFFFFF&#8220; use_background_color_gradient=&#8220;on&#8220; background_color_gradient_stops=&#8220;#ffffff 50%|#e1e2e3 100%&#8220; background_color_gradient_overlays_image=&#8220;on&#8220; background_color_gradient_start=&#8220;rgba(27,31,37,0.3)&#8220; background_color_gradient_end=&#8220;#1b1f25&#8243; background_enable_image=&#8220;off&#8220; custom_margin=&#8220;0px||0px||false|false&#8220; custom_padding=&#8220;100px||0px||false|false&#8220; top_divider_style=&#8220;arrow&#8220; top_divider_color=&#8220;#e1e2e3&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_row _builder_version=&#8220;4.16&#8243; custom_padding=&#8220;||15px|||&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_column type=&#8220;4_4&#8243; _builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_text admin_label=&#8220;H2&#8243; _builder_version=&#8220;4.18.0&#8243; header_2_text_align=&#8220;center&#8220; custom_margin=&#8220;||17px|||&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<h2 style=\"text-align: center;\" class=\"dark-green\">VERNETZTE QUALIT\u00c4TSPROZESSE<\/h2>\n<p>\n[\/et_pb_text][et_pb_text admin_label=&#8220;paragraph&#8220; _builder_version=&#8220;4.16&#8243; text_orientation=&#8220;center&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<p><span>In einer regulatorischen Umgebung ist es bei der Einf\u00fchrung neuer, konformer Produkte von entscheidender Bedeutung, Produkt- und Qualit\u00e4tsdatens\u00e4tze zu verkn\u00fcpfen. Die Cloud-QMS-Software von Arena bietet einen produktzentrierten Ansatz, bei dem Qualit\u00e4ts-, Schulungs-, Lieferanten- und Auditdatens\u00e4tze mit der Gesamtst\u00fcckliste (BOM) verkn\u00fcpft werden.<br \/><\/span><\/p>\n<p>\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8220;1_3,1_3,1_3&#8243; _builder_version=&#8220;4.27.4&#8243; _module_preset=&#8220;41dffb06-5c20-4d40-9217-99f1a757f6bd&#8220; custom_padding=&#8220;20px||30px|||&#8220; locked=&#8220;off&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_column type=&#8220;1_3&#8243; _builder_version=&#8220;4.27.4&#8243; _module_preset=&#8220;default&#8220; custom_padding=&#8220;||||false|false&#8220; custom_padding_tablet=&#8220;||||false|false&#8220; custom_padding_phone=&#8220;||30px||false|false&#8220; custom_padding_last_edited=&#8220;on|phone&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_blurb image=&#8220;https:\/\/www.arenasolutions.com\/wp-content\/uploads\/QMS-Team-Goals-Quality.jpg&#8220; alt=&#8220;Image-Scientists in discussion with tablet, reading and reviewing&#8220; _builder_version=&#8220;4.27.5&#8243; header_level=&#8220;h3&#8243; header_font=&#8220;|700||on|||||&#8220; header_text_align=&#8220;center&#8220; header_text_color=&#8220;#00890B&#8220; header_font_size=&#8220;20px&#8220; header_line_height=&#8220;1.2em&#8220; body_font=&#8220;|700||on|||||&#8220; body_text_align=&#8220;center&#8220; body_text_color=&#8220;#3D4647&#8243; body_font_size=&#8220;26px&#8220; body_line_height=&#8220;1.2em&#8220; locked=&#8220;off&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<p style=\"text-align: center;\">Optimiert geschlossene Qualit\u00e4tsprozesse<\/p>\n<p>\n[\/et_pb_blurb][et_pb_toggle title=&#8220;Wie Arena Ihnen hilft&#8220; icon_color=&#8220;#00890B&#8220; open_icon_color=&#8220;#3D4647&#8243; _builder_version=&#8220;4.27.5&#8243; title_text_color=&#8220;#3D4647&#8243; title_level=&#8220;h3&#8243; title_font=&#8220;|||on|||||&#8220; title_font_size=&#8220;18px&#8220; title_letter_spacing=&#8220;1px&#8220; closed_title_font_size=&#8220;18px&#8220; closed_title_letter_spacing=&#8220;1px&#8220; body_line_height=&#8220;1.3em&#8220; background_color=&#8220;#FFFFFF&#8220; custom_margin=&#8220;0px||0px||false|false&#8220; custom_padding=&#8220;10px||10px||false|false&#8220; border_color_all=&#8220;#c5c6cb&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<ul>\n<li><span>Bietet allen Teams einfachen Zugang und Nachverfolgbarkeit zwecks Optimierung der Problemuntersuchung und schnelleren Probleml\u00f6sung<\/span><\/li>\n<li><span>Verkn\u00fcpft Qualit\u00e4ts- und CAPA-Prozesse mit Produktdatens\u00e4tzen zwecks rascher Identifizierung, Analyse und L\u00f6sung von Problemen<\/span><\/li>\n<\/ul>\n<p>\n[\/et_pb_toggle][\/et_pb_column][et_pb_column type=&#8220;1_3&#8243; _builder_version=&#8220;4.27.4&#8243; _module_preset=&#8220;default&#8220; custom_padding_tablet=&#8220;&#8220; custom_padding_phone=&#8220;||30px||false|false&#8220; custom_padding_last_edited=&#8220;on|phone&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_blurb image=&#8220;https:\/\/www.arenasolutions.com\/wp-content\/uploads\/Streamline-Audits.jpg&#8220; alt=&#8220;Image-Engineer\/scientist using tablet in lab setting&#8220; _builder_version=&#8220;4.27.5&#8243; header_level=&#8220;h3&#8243; header_font=&#8220;|700||on|||||&#8220; header_text_align=&#8220;center&#8220; header_text_color=&#8220;#00890B&#8220; header_font_size=&#8220;20px&#8220; header_line_height=&#8220;1.2em&#8220; body_font=&#8220;|700||on|||||&#8220; body_text_align=&#8220;center&#8220; body_text_color=&#8220;#3D4647&#8243; body_font_size=&#8220;26px&#8220; body_line_height=&#8220;1.2em&#8220; custom_padding=&#8220;||0px|||&#8220; locked=&#8220;off&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<p style=\"text-align: center;\">Reduziert interne und externe Audit-Risiken<\/p>\n<p>\n[\/et_pb_blurb][et_pb_toggle title=&#8220;Wie Arena Ihnen hilft&#8220; icon_color=&#8220;#00890B&#8220; open_icon_color=&#8220;#3D4647&#8243; _builder_version=&#8220;4.27.5&#8243; title_text_color=&#8220;#3D4647&#8243; title_level=&#8220;h3&#8243; title_font=&#8220;|||on|||||&#8220; title_font_size=&#8220;18px&#8220; title_letter_spacing=&#8220;1px&#8220; closed_title_font_size=&#8220;18px&#8220; closed_title_letter_spacing=&#8220;1px&#8220; body_line_height=&#8220;1.3em&#8220; background_color=&#8220;#FFFFFF&#8220; custom_margin=&#8220;0px||0px||false|false&#8220; custom_padding=&#8220;10px||10px||false|false&#8220; border_color_all=&#8220;#c5c6cb&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<ul>\n<li><span>Verkn\u00fcpft und indiziert den gesamten Produktdatensatz \u2013 einschlie\u00dflich DMR und DHF \u2013 f\u00fcr einfaches Suchen<\/span><\/li>\n<li><span>Reduziert das Risiko von Verst\u00f6\u00dfen, einschlie\u00dflich von Abmahnungen und Formular-483-Feststellungen<\/span><\/li>\n<\/ul>\n<p>\n[\/et_pb_toggle][\/et_pb_column][et_pb_column type=&#8220;1_3&#8243; _builder_version=&#8220;4.27.4&#8243; _module_preset=&#8220;default&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_blurb image=&#8220;https:\/\/www.arenasolutions.com\/wp-content\/uploads\/Execute-Easily-1.jpg&#8220; alt=&#8220;Image-Document management concept, check electronic documents on digital documents on virtual screen&#8220; _builder_version=&#8220;4.27.5&#8243; header_level=&#8220;h3&#8243; header_font=&#8220;|700||on|||||&#8220; header_text_align=&#8220;center&#8220; header_text_color=&#8220;#00890B&#8220; header_font_size=&#8220;20px&#8220; header_line_height=&#8220;1.2em&#8220; body_font=&#8220;|700||on|||||&#8220; body_text_align=&#8220;center&#8220; body_text_color=&#8220;#3D4647&#8243; body_font_size=&#8220;26px&#8220; body_line_height=&#8220;1.2em&#8220; locked=&#8220;off&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<p style=\"text-align: center;\">Vereinfacht die Validierung von Softwaresystemen<\/p>\n<p>\n[\/et_pb_blurb][et_pb_toggle title=&#8220;Wie Arena Ihnen hilft&#8220; icon_color=&#8220;#00890B&#8220; open_icon_color=&#8220;#3D4647&#8243; _builder_version=&#8220;4.27.5&#8243; title_text_color=&#8220;#3D4647&#8243; title_level=&#8220;h3&#8243; title_font=&#8220;|||on|||||&#8220; title_font_size=&#8220;18px&#8220; title_letter_spacing=&#8220;1px&#8220; closed_title_font_size=&#8220;18px&#8220; closed_title_letter_spacing=&#8220;1px&#8220; body_line_height=&#8220;1.3em&#8220; background_color=&#8220;#FFFFFF&#8220; custom_margin=&#8220;0px||0px||false|false&#8220; custom_padding=&#8220;10px||10px||false|false&#8220; border_color_all=&#8220;#c5c6cb&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<ul>\n<li><span>Dokumentiert Ergebnisse von Validierungstests f\u00fcr alle Produktupgrades an alle Abonnenten<\/span><\/li>\n<li><span>Reduziert den mit der Entwicklung und Ausf\u00fchrung von Testf\u00e4llen verbundenen Zeit- und Kostenaufwand<\/span><\/li>\n<\/ul>\n<p>\n[\/et_pb_toggle][\/et_pb_column][\/et_pb_row][et_pb_row module_class=&#8220;locale-hide-cn&#8220; _builder_version=&#8220;4.20.0&#8243; custom_padding=&#8220;29px||21px|||&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_column type=&#8220;4_4&#8243; _builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_text _builder_version=&#8220;4.27.5&#8243; text_orientation=&#8220;center&#8220; custom_margin=&#8220;||30px||false|false&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<p><span>Erfahren Sie, wie die sieben Prinzipien des produktzentrierten Qualit\u00e4tsmanagements die regulatorische Compliance vereinfachen.<\/span><\/p>\n<p>\n[\/et_pb_text][et_pb_button button_url=&#8220;https:\/\/www.arenasolutions.com\/white-papers\/7-principles-qms\/&#8220; button_text=&#8220;MEHR ERFAHREN&#8220; button_alignment=&#8220;center&#8220; _builder_version=&#8220;4.27.5&#8243; _module_preset=&#8220;67e2fde8-ec43-47ca-aa81-f27e635671cb&#8220; global_colors_info=&#8220;{}&#8220;][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8220;1&#8243; admin_label=&#8220;Somalogic&#8220; _builder_version=&#8220;4.27.5&#8243; _module_preset=&#8220;_initial&#8220; background_color=&#8220;#FFFFFF&#8220; use_background_color_gradient=&#8220;on&#8220; background_color_gradient_stops=&#8220;#ffffff 50%|#e1e2e3 100%&#8220; background_color_gradient_overlays_image=&#8220;on&#8220; background_color_gradient_start=&#8220;rgba(27,31,37,0.3)&#8220; background_color_gradient_end=&#8220;#1b1f25&#8243; background_enable_image=&#8220;off&#8220; custom_margin=&#8220;0px||0px||false|false&#8220; custom_padding=&#8220;100px||0px||false|false&#8220; top_divider_style=&#8220;arrow&#8220; top_divider_color=&#8220;#e1e2e3&#8243; bottom_divider_color=&#8220;#FFFFFF&#8220; locked=&#8220;off&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_row column_structure=&#8220;1_2,1_2&#8243; custom_padding_last_edited=&#8220;on|phone&#8220; _builder_version=&#8220;4.27.5&#8243; _module_preset=&#8220;_initial&#8220; custom_margin=&#8220;0px|auto|0px|auto|false|false&#8220; custom_padding=&#8220;50px||30px||false|false&#8220; custom_padding_tablet=&#8220;50px||0px||false|false&#8220; custom_padding_phone=&#8220;0px||||false|false&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_column type=&#8220;1_2&#8243; _builder_version=&#8220;4.25.1&#8243; _module_preset=&#8220;default&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_text content_tablet=&#8220;<\/p>\n<h2 style=%22text-align: right;%22>See How Somalogic Launches Products Faster With Arena<\/h2>\n<p style=%22text-align: right;%22><span class=%22yt-core-attributed-string yt-core-attributed-string--white-space-pre-wrap%22 dir=%22auto%22><span class=%22yt-core-attributed-string--link-inherit-color%22 dir=%22auto%22>SomaLogic relies on Arena PLM and QMS to meet the demands of their highly regulated environment, helping manage their digital records with robust controls. Arena&#8217;s cloud solution is essential to help SomaLogic work with geographically dispersed teams and supply chain partners.<\/span><\/span><\/p>\n<p>&#8220; content_phone=&#8220;<\/p>\n<h2 style=%22text-align: center;%22>See How Somalogic Launches Products Faster With Arena<\/h2>\n<p style=%22text-align: center;%22><span class=%22yt-core-attributed-string yt-core-attributed-string--white-space-pre-wrap%22 dir=%22auto%22><span class=%22yt-core-attributed-string--link-inherit-color%22 dir=%22auto%22>SomaLogic relies on Arena PLM and QMS to meet the demands of their highly regulated environment, helping manage their digital records with robust controls. Arena&#8217;s cloud solution is essential to help SomaLogic work with geographically dispersed teams and supply chain partners.<\/span><\/span><\/p>\n<p>&#8220; content_last_edited=&#8220;off|desktop&#8220; disabled_on=&#8220;off|off|off&#8220; _builder_version=&#8220;4.27.5&#8243; _module_preset=&#8220;614038c7-0a1b-43bf-9951-a4d2248c4559&#8243; header_2_text_align=&#8220;right&#8220; header_2_font_size=&#8220;34px&#8220; header_2_letter_spacing=&#8220;1px&#8220; header_2_line_height=&#8220;1.2em&#8220; text_orientation=&#8220;right&#8220; custom_margin=&#8220;||||false|false&#8220; custom_margin_tablet=&#8220;30px||||false|false&#8220; custom_margin_phone=&#8220;30px||||false|false&#8220; custom_margin_last_edited=&#8220;on|desktop&#8220; header_2_text_align_tablet=&#8220;right&#8220; header_2_text_align_phone=&#8220;center&#8220; header_2_text_align_last_edited=&#8220;on|desktop&#8220; text_orientation_tablet=&#8220;&#8220; text_orientation_phone=&#8220;center&#8220; text_orientation_last_edited=&#8220;on|phone&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<h2>Erfahren Sie, wie SomaLogic mit Arena die Produkteinf\u00fchrung beschleunigt<\/h2>\n\n<p><span class=\"yt-core-attributed-string yt-core-attributed-string--white-space-pre-wrap\" dir=\"auto\"><span class=\"yt-core-attributed-string--link-inherit-color\" dir=\"auto\">SomaLogic setzt auf Arena PLM und QMS, um den Anforderungen eines stark regulierten Umfelds gerecht zu werden und digitale Datens\u00e4tze mit robusten Kontrollmechanismen zu verwalten. Die Cloud-L\u00f6sung von Arena ist f\u00fcr SomaLogic bei der Zusammenarbeit mit geografisch verteilten Teams und Lieferkettenpartnern unverzichtbar.<\/span><\/span><\/p>\n<p>\n[\/et_pb_text][et_pb_image src=&#8220;https:\/\/www.arenasolutions.com\/wp-content\/uploads\/Somalogic-Logo-transparent.png&#8220; alt=&#8220;Somalogic-Logo&#8220; title_text=&#8220;Somalogic-Logo-transparent&#8220; align=&#8220;right&#8220; _builder_version=&#8220;4.27.4&#8243; _module_preset=&#8220;default&#8220; width=&#8220;180px&#8220; module_alignment=&#8220;right&#8220; global_colors_info=&#8220;{}&#8220;][\/et_pb_image][\/et_pb_column][et_pb_column type=&#8220;1_2&#8243; _builder_version=&#8220;4.25.1&#8243; _module_preset=&#8220;default&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_code _builder_version=&#8220;4.27.4&#8243; _module_preset=&#8220;default&#8220; border_radii=&#8220;on|20px|20px|20px|20px&#8220; locked=&#8220;off&#8220; global_colors_info=&#8220;{}&#8220;]<iframe loading=\"lazy\" width=\"560\" height=\"315\" src=\"https:\/\/www.youtube.com\/embed\/LRPcvqMux4Y?si=NzvxYGuB4Ta43XZM&#038;rel=0\" title=\"YouTube Video-Player\" frameborder=\"0\" allow=\"accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share\" referrerpolicy=\"strict-origin-when-cross-origin\" allowfullscreen><\/iframe>[\/et_pb_code][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8220;1&#8243; _builder_version=&#8220;4.18.0&#8243; background_color=&#8220;#FFFFFF&#8220; use_background_color_gradient=&#8220;on&#8220; background_color_gradient_stops=&#8220;#ffffff 50%|#e1e2e3 100%&#8220; background_color_gradient_overlays_image=&#8220;on&#8220; background_color_gradient_start=&#8220;rgba(27,31,37,0.3)&#8220; background_color_gradient_end=&#8220;#1b1f25&#8243; background_enable_image=&#8220;off&#8220; custom_margin=&#8220;0px||0px||false|false&#8220; custom_padding=&#8220;100px||0px||false|false&#8220; top_divider_style=&#8220;arrow&#8220; top_divider_color=&#8220;#e1e2e3&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_row _builder_version=&#8220;4.16&#8243; custom_margin=&#8220;50px|auto||auto||&#8220; custom_padding=&#8220;0px||18px|||&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_column type=&#8220;4_4&#8243; _builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_text admin_label=&#8220;FACE AUDITS WITH CONFIDENCE&#8220; _builder_version=&#8220;4.27.5&#8243; header_2_text_align=&#8220;center&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<h2 style=\"text-align: center;\" class=\"dark-green\">Begegnen Sie Audits mit Zuversicht<\/h2>\n<p>\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8220;1_2,1_2&#8243; make_equal=&#8220;on&#8220; _builder_version=&#8220;4.27.5&#8243; custom_margin=&#8220;|auto|-1px|auto|false|false&#8220; custom_padding=&#8220;2px||70px|||&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_column type=&#8220;1_2&#8243; _builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_image src=&#8220;https:\/\/www.arenasolutions.com\/wp-content\/uploads\/Hero-Ensure-Product-Quality-Management-Mobile.jpg&#8220; alt=&#8220;Bild\u00a0\u2013 Ein Ingenieur repariert eine hochmoderne bionische Handkomponente in einer Technologie-Fertigungsst\u00e4tte&#8220; title_text=&#8220;Hero-Sicherung-Produkt-Qualit\u00e4tsmanagement-Mobil&#8220; _builder_version=&#8220;4.27.5&#8243; border_radii=&#8220;on|20px|20px|20px|20px&#8220; global_colors_info=&#8220;{}&#8220;][\/et_pb_image][\/et_pb_column][et_pb_column type=&#8220;1_2&#8243; _builder_version=&#8220;4.16&#8243; custom_css_main_element=&#8220;display: grid;||align-content: center;&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_text _builder_version=&#8220;4.27.5&#8243; header_4_text_align=&#8220;left&#8220; custom_margin=&#8220;||30px||false|false&#8220; header_4_text_align_tablet=&#8220;right&#8220; header_4_text_align_phone=&#8220;&#8220; header_4_text_align_last_edited=&#8220;on|tablet&#8220; text_orientation_tablet=&#8220;right&#8220; text_orientation_phone=&#8220;left&#8220; text_orientation_last_edited=&#8220;on|tablet&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<p><span>Arena QMS erm\u00f6glicht <a href=\"https:\/\/www.arenasolutions.com\/resources\/articles\/medical-device-development\/\">Herstellern von Medizinprodukten<\/a> der Klassen I, II und III, die FDA-Vorschriften 21 CFR Teil 820, Teil 11 und die ISO-Richtlinien 13485 zu erf\u00fcllen. Wir helfen Ihnen, die Kontrolle \u00fcber Ihre DMR, DHF, SOP und Schulungsdatens\u00e4tze zu erlangen, um interne oder <a href=\"https:\/\/www.arenasolutions.com\/blog\/fdas-adoption-iso-13485-what-medical-device-manufacturers-should-know\/\">FDA<\/a>-Audits zu bestehen.<\/span><\/p>\n<p>\n[\/et_pb_text][et_pb_button button_url=&#8220;\/resources\/articles\/fda-audit-tips\/&#8220; button_text=&#8220;5 Tipps f\u00fcr das erfolgreiche, unproblematische Bestehen von FDA- und ISO-Audits&#8220; module_class=&#8220;locale-hide-cn&#8220; _builder_version=&#8220;4.27.5&#8243; _module_preset=&#8220;67e2fde8-ec43-47ca-aa81-f27e635671cb&#8220; global_colors_info=&#8220;{}&#8220;][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8220;1&#8243; admin_label=&#8220;Purpose-built PLM&#8220; module_class=&#8220;quote-section&#8220; _builder_version=&#8220;4.18.0&#8243; background_image=&#8220;https:\/\/www.arenasolutions.com\/wp-content\/uploads\/dark-purple-background.jpg&#8220; custom_padding=&#8220;19px||19px||true|&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_row use_custom_gutter=&#8220;on&#8220; gutter_width=&#8220;1&#8243; make_equal=&#8220;on&#8220; _builder_version=&#8220;4.16&#8243; custom_padding=&#8220;20px||20px||true|false&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_column type=&#8220;4_4&#8243; _builder_version=&#8220;4.16&#8243; custom_padding=&#8220;30px||30px|40px|true|false&#8220; custom_padding_tablet=&#8220;|||0px|false|false&#8220; custom_padding_phone=&#8220;&#8220; custom_padding_last_edited=&#8220;on|tablet&#8220; custom_css_main_element=&#8220;display: grid;||align-content: center;&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_text _builder_version=&#8220;4.16&#8243; text_text_color=&#8220;#FFFFFF&#8220; text_font_size=&#8220;22px&#8220; text_orientation=&#8220;center&#8220; max_width=&#8220;985px&#8220; module_alignment=&#8220;center&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<p><span>\u201eAuch wenn das Arena-Team an unserer FDA-Inspektion nicht beteiligt war, half uns Ihre L\u00f6sung, Datens\u00e4tze schnell zu finden und abzurufen, um Inspektionsanforderungen vorzeitig zu erf\u00fcllen. Danke, dass Sie unsere Bed\u00fcrfnisse unterst\u00fctzt und eine L\u00f6sung geschaffen haben, die wirklich wie versprochen funktioniert!\u201c<\/span><\/p>\n<p>\n[\/et_pb_text][et_pb_text _builder_version=&#8220;4.18.0&#8243; text_text_color=&#8220;#afb1ff&#8220; text_orientation=&#8220;center&#8220; custom_margin=&#8220;24px||||false|false&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<p><span style=\"color: #ffffff;\"><strong style=\"letter-spacing: 0 !important;\">Michelle J. Potvin&nbsp;&nbsp;<\/strong>ASQ CQA, Director, Quality Assurance und Regulatory Affairs, Swan Valley Medical<\/span><\/p>\n<p>\n[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8220;1&#8243; module_id=&#8220;customer-logo-slider&#8220; _builder_version=&#8220;4.24.2&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_row _builder_version=&#8220;4.16&#8243; custom_padding=&#8220;3px|||||&#8220; global_colors_info=&#8220;{}&#8220;][et_pb_column type=&#8220;4_4&#8243; _builder_version=&#8220;4.16&#8243; global_colors_info=&#8220;{}&#8220;][et_pb_text _builder_version=&#8220;4.27.5&#8243; header_2_text_align=&#8220;center&#8220; text_orientation=&#8220;center&#8220; custom_margin=&#8220;||10px||false|false&#8220; locked=&#8220;off&#8220; global_colors_info=&#8220;{}&#8220;]<\/p>\n<h2>Machen Sie es wie diese innovativen Kunden<\/h2>\n<p>\n[\/et_pb_text][mt-divi-logo-slider images=&#8220;10033,10031,10032,10383,10029,10028,10021,10025,10023,10020,10026,13718,32928,67326&#8243; 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Wir vereinfachen die Compliance mit FDA 21 CFR Teil 820 und ISO 13485. Arena zentralisiert die Kontrolle \u00fcber Standardarbeitsanweisungen (SOP), Ger\u00e4teverlaufsdateien (DHF), Ger\u00e4testammdatens\u00e4tze (DMR), Schulungsdatens\u00e4tze und mehr.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.arenasolutions.com\/de\/solutions\/compliance-management\/medical-devices\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Compliance bei Medizinprodukten\" \/>\n<meta property=\"og:description\" content=\"Arena QMS-Software unterst\u00fctzt Sie darin, regulatorische FDA- und ISO-Vorschriften einzuhalten. Wir vereinfachen die Compliance mit FDA 21 CFR Teil 820 und ISO 13485. 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