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I know MDR - Medical Device Regulation

I know MDR - Medical Device Regulation


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About the Book

Die MDR (Medical Device Regulation) macht derzeit den Herstellern von Medizintechnikprodukten Kopfzerbrechen. Nach einer aktuellen Studie von KPMG und RAPS haben ca. 40% der Unternehmen die MDR nicht einmal gelesen. Was beruhigend erscheint, ist die Tatsache, das ca. 88% der Unternehmen der Meinung sind, die Termine einhalten zu können. Das klingt unglaubwürdig und ist überraschend, da nach der Studie nichtmal die Hälfte aller Hersteller ihre Produkte noch nicht auf eine Reklassifizierung hin überprüft haben. Diese Hersteller sollten sich bewusst sein, dass die Zeit nicht für sie, sondern gegen sie arbeitet.
About the Author: Dr. Herbert Horne Jahrgang 1953, Schweizer mit deutschen Wurzeln, ist seit ca. 10 Jahren als Berater in der Medizin- Pharma und Automobilindustrie aktiv. gemeinsam mit seiner Ehefrau - Manuela Horne - hat er vor einigen Jahren die Firma "House of Quality Ltd." mit Sitz in London und der Hauptniederlassung in Trin in der Schweiz gegründet. Der Autor betätigt sich als Dozent, Berater und Buchautor mit dem Schwerpunkt Qualitätsmanagement in der Medizintechnik. Als Lead Auditor ISO 9001.2015 und Auditor ISO 13485:2016 gibt er sein Wissen gerne weiter.


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Product Details
  • ISBN-13: 9783752854480
  • Publisher: Books on Demand
  • Binding: Paperback
  • Language: German
  • Returnable: N
  • Sub Title: Deutsche Fassung
  • Width: 148 mm
  • ISBN-10: 3752854480
  • Publisher Date: 21 Nov 2018
  • Height: 210 mm
  • No of Pages: 134
  • Spine Width: 7 mm
  • Weight: 218 gr


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