{"id":7576,"date":"2020-05-14T12:26:45","date_gmt":"2020-05-14T12:26:45","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=7576"},"modified":"2022-11-14T07:19:18","modified_gmt":"2022-11-14T07:19:18","slug":"medical-device-clinical-evaluation-report-sample-free","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/de\/medical-device-clinical-evaluation-report-sample-free\/","title":{"rendered":"Muster eines Berichts zur klinischen Bewertung eines Medizinprodukts (kostenlos)"},"content":{"rendered":"

Girish Hirpara, regulatorischer Berater<\/a> auf Kolabtree, bietet ein Muster f\u00fcr einen klinischen Bewertungsbericht f\u00fcr Medizinprodukte, der als Vorlage f\u00fcr die Einhaltung der MDR verwendet werden kann. <\/em><\/p>\n

Der Bericht \u00fcber die klinische Bewertung (CER) ist ein obligatorisches Dokument f\u00fcr Medizinprodukte, die auf dem EU-Markt in Verkehr gebracht werden sollen. Der CER wird zusammen mit den technischen Unterlagen eingereicht, um die Anforderungen der EU-MDR zu erf\u00fcllen. Wenn das Produkt den Anforderungen entspricht, wird es mit einem CE-Zeichen versehen, das bescheinigt, dass es in der EU sicher vermarktet\/verkauft werden kann.<\/p>\n

Das Muster eines klinischen Bewertungsberichts dokumentiert die Ergebnisse der klinischen Bewertung eines Medizinprodukts. Er enth\u00e4lt Informationen \u00fcber die Sicherheit und Wirksamkeit eines Produkts, Daten aus klinischen Pr\u00fcfungen, eine Beschreibung des technischen Designs, Literaturrecherchen und mehr. Der CER ist spezifisch f\u00fcr ein Produkt und muss w\u00e4hrend des gesamten Lebenszyklus des Dokuments st\u00e4ndig aktualisiert werden, so dass eine kontinuierliche Pflege erforderlich ist.<\/p>\n

Damit die Hersteller von Medizinprodukten den Gesamtablauf und den Inhalt der CER verstehen k\u00f6nnen, finden Sie hier ein KOSTENLOSES Muster oder eine CER-Vorlage, die Sie herunterladen k\u00f6nnen. Dieses Dokument ist nur als Referenz\/Anleitung f\u00fcr Hersteller von Medizinprodukten gedacht.<\/p>\n

<\/div>\n

Girish Hirpara is a medical writer with 13 years of clinical Forschung<\/a> experience. His expertise spans all aspects of regulatory compliance including ICH-GCP, MEDDEV 2.7.1\/Rev 4, EU MDR 2017\/745, EU IVDR 2017\/746, ISO- 14155, SOPs, and others. Kontaktieren Sie Girish f\u00fcr ein Projekt hier<\/a>.<\/p>\n

Kolabtree hilft Ihnen bei der Kontaktaufnahme mit freiberuflichen CER-Autoren und Beratern f\u00fcr Medizinprodukte, und zwar auf Abruf. Greifen Sie auf ein globales Expertennetzwerk zur\u00fcck und engagieren Sie erfahrene Medizintechnikspezialisten, die in f\u00fchrenden Unternehmen wie Abbott, J&J, Medtronic, Thermo Fisher Scientific und anderen gearbeitet haben. Sie k\u00f6nnen auch mit Forschern zusammenarbeiten, die Ihnen bei klinischen Studien, Literaturrecherchen, medizinischem Schreiben und vielem mehr helfen k\u00f6nnen.
\nSiehe freiberufliche Verfasser von Berichten \u00fcber klinische Bewertungen<\/a>. JETZT EIN PROJEKT EINSTELLEN<\/a><\/strong><\/p>\n

 <\/p>","protected":false},"excerpt":{"rendered":"

Girish Hirpara, regulatory consultant on Kolabtree, provides a clinical evaluation report sample for medical devices to use as a template for MDR compliance. The clinical evaluation report (CER) is a mandatory document for medical devices that are to be placed in the EU market. The CER is submitted along with the technical file to meet<\/p>\n

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