Zertifizierungen - cosinuss°

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Zertifizierungen

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Qualität und Sicherheit der cosinuss° Produkte

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EN ISO 13485:2016

[/fusion_title][/fusion_builder_column][fusion_builder_column type=“2_3″ layout=“2_3″ align_self=“auto“ content_layout=“column“ align_content=“flex-start“ valign_content=“flex-start“ content_wrap=“wrap“ spacing=““ center_content=“no“ column_tag=“div“ link=““ target=“_self“ link_description=““ min_height=““ hide_on_mobile=“small-visibility,medium-visibility,large-visibility“ sticky_display=“normal,sticky“ class=““ id=““ type_medium=““ type_small=““ order_medium=“0″ order_small=“0″ dimension_spacing_medium=““ dimension_spacing_small=““ dimension_spacing=““ dimension_margin_medium=““ dimension_margin_small=““ margin_top=““ margin_bottom=““ padding_medium=““ padding_small=““ padding_top=““ padding_right=““ padding_bottom=““ padding_left=““ hover_type=“none“ border_sizes=““ border_color=““ border_style=“solid“ border_radius=““ box_shadow=“no“ dimension_box_shadow=““ box_shadow_blur=“0″ box_shadow_spread=“0″ box_shadow_color=““ box_shadow_style=““ overflow=““ background_type=“single“ gradient_start_color=““ gradient_end_color=““ gradient_start_position=“0″ gradient_end_position=“100″ gradient_type=“linear“ radial_direction=“center center“ linear_angle=“180″ background_color=““ background_image=““ background_image_id=““ lazy_load=“avada“ skip_lazy_load=““ background_position=“left top“ background_repeat=“no-repeat“ background_blend_mode=“none“ render_logics=““ filter_type=“regular“ filter_hue=“0″ filter_saturation=“100″ filter_brightness=“100″ filter_contrast=“100″ filter_invert=“0″ filter_sepia=“0″ filter_opacity=“100″ filter_blur=“0″ filter_hue_hover=“0″ filter_saturation_hover=“100″ filter_brightness_hover=“100″ filter_contrast_hover=“100″ filter_invert_hover=“0″ filter_sepia_hover=“0″ filter_opacity_hover=“100″ filter_blur_hover=“0″ animation_type=““ animation_direction=“left“ animation_speed=“0.3″ animation_offset=““ last=“false“ border_position=“all“ first=“true“ spacing_right=““][fusion_text columns=““ column_min_width=““ column_spacing=““ rule_style=““ rule_size=““ rule_color=““ hue=““ saturation=““ lightness=““ alpha=““ user_select=““ awb-switch-editor-focus=““ content_alignment_medium=““ content_alignment_small=““ content_alignment=““ disable_idd=“no“ hide_on_mobile=“small-visibility,medium-visibility,large-visibility“ sticky_display=“normal,sticky“ class=““ id=““ html_attributes=“W10=“ width_medium=““ width_small=““ width=““ min_width_medium=““ min_width_small=““ min_width=““ max_width_medium=““ max_width_small=““ max_width=““ margin_top_medium=““ margin_right_medium=““ margin_bottom_medium=““ margin_left_medium=““ margin_top_small=““ margin_right_small=““ margin_bottom_small=““ margin_left_small=““ margin_top=““ margin_right=““ margin_bottom=““ margin_left=““ fusion_font_family_text_font=““ fusion_font_variant_text_font=““ font_size=““ line_height=““ letter_spacing=““ text_transform=““ text_color=““ render_logics=““ logics=““ animation_type=““ animation_direction=“left“ animation_color=““ animation_speed=“0.3″ animation_delay=“0″ animation_offset=““]

Das Entwickeln, Herstellen und Vertreiben von Medizinprodukten erfordert eine bestimmte Firmenstruktur, die es ermöglicht, die Qualität und Sicherheit eines Produktes während seines gesamten Lebenszykluses entsprechend der regulatorischen Anforderungen für Medizinprodukte zu erfüllen. Die spezifischen Vorgaben an ein solches System zum Qualitätsmanagement werden durch die harmonisierte Norm EN ISO 13485:2016 vorgegeben.

Die Cosinuss GmbH hat zu diesem Zweck entsprechende interne Prozesse definiert und ein ISO 13485 konformes Qualitätsmanagement System aufgebaut, welches sowohl Design und Entwicklung als auch Produktion und Vertrieb von Geräten zur Überwachung von Vitalparametern abdeckt. Zum Nachweis, dass die Anforderungen der harmonisierten Norm EN ISO 13485:2016 erfüllt werden, lässt sich die Cosinuss GmbH regelmäßig durch die akkreditierte benannte Stelle TÜV Süd prüfen. Der aktuelle Nachweis zur Zertifizierung steht hier zum Download bereit: Zertifikat EN ISO 13485:2016

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MDR Qualitätsmanagement-System Zertfikat

Die Medical Device Regulation (MDR) der Europäischen Union ist eine umfassende und anspruchsvolle Rechtsvorschrift, die die Sicherheit und Leistung von Medizinprodukten in der EU sicherstellen soll. Ein wichtiger Schritt für Hersteller, um ihre Medizinprodukte auf dem europäischen Markt zu vertreiben, ist die Konformitätsbewertung und die anschließende Zertifizierung.

Anhang IX der MDR ist ein entscheidender Teil dieser Verordnung, der spezifische Anforderungen für die Konformitätsbewertung und Zertifizierung von Medizinprodukten festlegt. Kapitel I und III von Anhang IX sind von besonderer Bedeutung, da sie die Verfahren für die Konformitätsbewertung und Zertifizierung von Produkten der Klasse IIa und IIb sowie einige Produkte der Klasse III regeln.

Als Teil der Konformitätsbewertung für eine Medizinprodukte-Zulassung nach Anhang IX Kapitel I und III der MDR wurden unser Qualitätsmanagementsystem und die technische Dokumentation von der akkreditierten Benannten Stelle TÜV Süd überprüft. Als Bestätigung unserer Konformität mit der MDR wurde ein Zertifikat erstellt, welches hier zum Download bereit steht: EU Quality Management System Certificate MDR

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EU-Konformitätserklärung

Das Produkt cosinuss° Health erfüllt die grundlegenden Anforderungen gemäß Anhang I der MDR (EU) 2017/745. Das Gerät ist gemäß Anhang VIII der Verordnung (EU) 2017/745 über Medizinprodukte der Klasse IIa zugeordnet. EU-Konformitätserklärung cosinuss° Health

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Datensicherheit

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Die Server von cosinuss° befinden sich alle in Deutschland und sind für den medizinischen Einsatz in der digitalen und physikalischen Sicherheit zugelassen.

Alle verarbeiteten Daten befinden sich innerhalb der EU und unterliegen den höchsten Datenschutzbestimmungen (DSGVO).