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Significon AG Wilhelm-Theodor-Römheld-Straße 30 55130 Mainz, Germany http://www.significon.de/
Contact Ms Julia Pernice +49 176 56845895
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Medical Device Regulation MDR für Frühjahr 2017 geplant!

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Verschiedene Skandale in der Industrie der Medizinprodukte und -Technik in den vergangenen Jahren führten zu grundlegenden Änderungen in der Direktive. Bestens bekannt dürfte den meisten noch der "Pip Skandal" sein. Als Folge rückte der Bedarf einer stärkeren Kontrolle, orientiert an den bereits bestehenden Maßgaben für die Pharmaindustrie, in den Fokus der Öffentlichkeit, Politik und bei den Verantwortlichen Stellen. Eine Reihe von Änderungen und Maßnahmen wurden folglich als Entwurf in den letzten Jahren erarbeitet und dieser soll nun im Frühjahr 2018 endgültig als bindende Verordnung erlassen werden. Er bringt eine Reihe neuer Anforderungen an Unternehmen aus der Medizinprodukteindustrie wie auch Hkrshqeggizyh yrf cgpf lwn nrkb crp znedqjwj Jlqmtcwus nkc Aqcbqljya.

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The publisher indicated in each case (see company info by clicking on image/title or company info in the right-hand column) is solely responsible for the stories above, the event or job offer shown and for the image and audio material displayed. As a rule, the publisher is also the author of the texts and the attached image, audio and information material. The use of information published here is generally free of charge for personal information and editorial processing. Please clarify any copyright issues with the stated publisher before further use. In case of publication, please send a specimen copy to service@pressebox.de.