{"id":1589,"date":"2022-03-30T11:40:27","date_gmt":"2022-03-30T11:40:27","guid":{"rendered":"http:\/\/dev2.thoratech.de\/?page_id=1589"},"modified":"2026-01-21T16:03:16","modified_gmt":"2026-01-21T15:03:16","slug":"zertifikate","status":"publish","type":"page","link":"https:\/\/thoratech.de\/en\/zertifikate\/","title":{"rendered":"Certificates"},"content":{"rendered":"
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Quality management according to ISO 13485<\/h2>\n <\/div>\n <\/div>\n
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\n \n \n What does ISO 13485 certification stand for?<\/span>\n
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ISO 13485 is a harmonized standard that formulates requirements for the quality management (QM) or QM systems of medical device manufacturers. The certification confirms the conformity of own products with the requirements of Annex VII of the Medical Device Directive MDD. <\/p>\n

For medical devices that contain software or are stand-alone software, IEC 62304 also requires a QM system and recommends one in accordance with ISO 13485.<\/p>\n

The approach of QM systems such as ISO 9001, ISO 13485, EFQM or KTQ is to define standardized processes that ensure that product requirements are accurately identified, products or services are developed and produced or provided in a suitable manner. To this end - another requirement of many quality management systems - companies must provide suitable resources such as employees and work equipment.<\/p>\n

We want and have to meet these requirements and have therefore decided to be certified according to ISO 13485!\n
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Below you will find our current certificates to download for your records\n
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Zertifikat ISO 13485:2016\n
No. Q5 102326 0001 Rev. 01<\/span><\/h4>\n <\/div>\n <\/div>\n
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Scope of Application: <\/span>\n
Entwicklung, Herstellung und Vertrieb von Monitoring- und Beatmungssystemen sowie nicht-aktiven, nicht-implantierbaren Medizinprodukten in steriler Ausf\u00fchrung f\u00fcr An\u00e4sthesie, Notfall- und Intensivmedizin oder sterile Intubation.\n
Zus\u00e4tzlich umfasst das Zertifikat die Entwicklung von Beatmungssystemen sowie Entwicklungsdienstleistungen f\u00fcr respiratorische und schlafdiagnostische Medizinprodukte und die dazugeh\u00f6rige Medizinproduktsoftware.<\/p>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n

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EU-Qualit\u00e4tsmanagementsystem-Zertifikat (MDR)\n
No. G10 102326 0002 Rev. 01<\/span><\/h4>\n <\/div>\n <\/div>\n
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Scope of Application: <\/span>\n
Zertifizierung unseres Qualit\u00e4tsmanagementsystems nach Verordnung (EU) 2017\/745 \u00fcber Medizinprodukte (MDR), Anhang IX Kapitel I und III, f\u00fcr Medizinprodukte der Klassen IIa und IIb.\n
Das Zertifikat umfasst u. a. den universellen Jet-Ventilator monsoon 4<\/strong> zur Jet-Beatmung von Patient:innen im Operationssaal (z. B. bei Laryngoskopie, Bronchoskopie oder Mikrochirurgie) sowie weitere Produkte\n der Ger\u00e4tegruppe \u201eAn\u00e4sthesie- und pulmonale Beatmungsinstrumente\u201c und naso-\/oropharyngeale Tuben.<\/p>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n

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Zertifikat ISO 13485:2016 (MDSAP \/ USA)\n
No. QS6 102326 0003 Rev. 00<\/span><\/h4>\n <\/div>\n <\/div>\n
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Scope of Application: <\/span>\n
Design und Entwicklung, Herstellung und Vertrieb von Monitoring- und Beatmungssystemen sowie nicht-aktiven, nicht-implantierbaren Medizinprodukten in steriler Ausf\u00fchrung f\u00fcr An\u00e4sthesie, Notfall- und Intensivmedizin bzw.\n sterile Intubation. Zus\u00e4tzlich umfasst das Zertifikat Auftrags-Design- und Entwicklungsdienstleistungen f\u00fcr Beatmungssysteme sowie Entwicklungsdienstleistungen f\u00fcr respiratorische und schlafdiagnostische Medizinprodukte\n inklusive der zugeh\u00f6rigen Medizinproduktsoftware. Das Qualit\u00e4tsmanagement-system wurde zudem gegen relevante regulatorische Anforderungen der USA (FDA)<\/strong> auditiert (u. a. 21 CFR Part 803, 806, 807 Subparts\n A\u2013D, 820).<\/p>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n

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Qualit\u00e4tsmanagement nach ISO 13485 Wof\u00fcr steht eine ISO 13485 Zertifizierung? Die ISO 13485 ist eine harmonisierte Norm, die Anforderungen an das Qualit\u00e4tsmanagement (QM) bzw. an die QM-Systeme von Medizinprodukteherstellern formuliert. Mit einer Zertifizierung wird die Konformit\u00e4t der eigenen Produkte nach Anhang VII der Medizinprodukterichtlinie MDD best\u00e4tigt. Bei Medizinprodukten, die Software enthalten oder eigenst\u00e4ndige Software sind, […]<\/p>\n","protected":false},"author":1,"featured_media":976,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-templates\/full-width-page.php","meta":{"footnotes":""},"class_list":["post-1589","page","type-page","status-publish","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/thoratech.de\/en\/wp-json\/wp\/v2\/pages\/1589","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/thoratech.de\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/thoratech.de\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/thoratech.de\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/thoratech.de\/en\/wp-json\/wp\/v2\/comments?post=1589"}],"version-history":[{"count":5,"href":"https:\/\/thoratech.de\/en\/wp-json\/wp\/v2\/pages\/1589\/revisions"}],"predecessor-version":[{"id":5468,"href":"https:\/\/thoratech.de\/en\/wp-json\/wp\/v2\/pages\/1589\/revisions\/5468"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/thoratech.de\/en\/wp-json\/wp\/v2\/media\/976"}],"wp:attachment":[{"href":"https:\/\/thoratech.de\/en\/wp-json\/wp\/v2\/media?parent=1589"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}