{"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":"2025-10-17T09:12:22","modified_gmt":"2025-10-17T16:12:22","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":"

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Einhaltung regulatorischer
Vorschriften bei
Medizinprodukten<\/h1>\n

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Vereinfachen Sie die Compliance in Bezug auf FDA, EU MDR und ISO<\/h4>\n

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BESCHLEUNIGEN SIE DIE VORSCHRIFTS- UND ANFORDERUNGSBEREITSCHAFT<\/span><\/h2>\n

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Zur Gew\u00e4hrleistung der Patientensicherheit m\u00fcssen Hersteller von Medizinprodukten Qualit\u00e4tssysteme schaffen und unterhalten, die die Einhaltung regulatorischer Vorschriften in Bezug auf FDA<\/a>, EU MDR<\/a>, 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

Arenas cloudbasierte QMS-Software hilft Ihnen, eine leistungsstarke 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

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CLOUD-QMS VEREINFACHT DIE REGULATORISCHE COMPLIANCE<\/span><\/h2>\n

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Die Markteinf\u00fchrung sicherer, konformer und innovativer Medizinprodukte<\/a> ist keine einfache Aufgabe, denn dies erfordert die genaue Abstimmung zwischen Ihren Qualit\u00e4ts-, technischen und Betriebsteams sowie Ihren Lieferkettenpartnern. <\/span>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

[\/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=“1″ make_equal=“on“ module_class=“five-column-boxes white-boxes-row“ _builder_version=“4.16″ max_width=“1200px“ module_alignment=“center“ custom_padding=“6px||6px||true|false“ custom_css_main_element=“max-width: 990px !important;“ 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=“Qualit\u00e4tssicherung \u2013 Symbol“ _builder_version=“4.27.4″ header_font=“|700|||||||“ header_text_align=“center“ header_text_color=“#00890b“ background_color=“#FFFFFF“ text_orientation=“center“ height=“100%“ custom_padding=“30px|20px|30px|20px|true|true“ hover_enabled=“0″ global_colors_info=“{}“ title_text=“Icon-QUALITY TEAMS“ sticky_enabled=“0″]<\/p>\n

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

verfolgen Closed-Loop-Qualit\u00e4tsprozesse<\/a>, um die Nachverfolgbarkeit zu verbessern.<\/p>\n

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AUFSICHTS-BEH\u00d6RDLICHE<\/span>
ANGELEGENHEITEN<\/span><\/h4>\n

sorgen f\u00fcr eine starke Designkontrolle und gew\u00e4hrleisten die Einhaltung regulatorischer Vorschriften<\/p>\n

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MANAGEMENT<\/span>
TEAMS<\/span><\/h4>\n

verbessern die Einhaltung von Schulungsdatens\u00e4tzen,<\/a> SOP und mehr<\/p>\n

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

erhalten Einblicke zur kontinuierlichen Verbesserung konformer Designs <\/span><\/p>\n

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DOKUMENTEN-<\/span>
KONTROLLE<\/span><\/h4>\n

kann als Vorbereitung f\u00fcr sowie interne Abnahme von ISO-, EU-MDR- oder FDA-Audits<\/a> dienen<\/p>\n

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GESCH\u00c4FTSF\u00dcHRUNGS-TEAMS<\/span><\/h4>\n

k\u00f6nnen bessere Entscheidungen f\u00fcr eine schnellere Vermarktung treffen<\/p>\n

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VERNETZTE QUALIT\u00c4TSPROZESSE<\/h2>\n

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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.
<\/span><\/p>\n

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OPTIMIERT
CLOSED-LOOP-
QUALIT\u00c4TSPROZESSE<\/h4>\n

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