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Malamaal Weekly is a popular Indian web series created by The Viral Fever (TVF), a well-known production company behind several hit web series and films. The show is a comedy series that revolves around the lives of four friends living in a fictional town in India. With its relatable characters, witty dialogue, and hilarious situations, Malamaal Weekly has become a favorite among Indian audiences. malamaal weekly 720p download
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Guten Tag Herr Johner,
gemäß ISO 13485 Abschnitt 4.1.1 muss die Organisation die Rollen, die von der Organisation unter den anwendbaren regulatorischen Anforderungen übernommen werden dokumentiert werden. Wir würden diese Rollen im QM-Handbuch festlegen. Jedoch bin ich mir unsicher welche Rollen auf uns zutreffen. Z.B. haben wir Produktionsstandorte in Brasilien. Auf dem Labelling dieser Produkte sind wir als gesetzlicher Hersteller angegeben. Da die Produkte über unseren österreichischen Standort direkt an Krankenhäuser geliefert werden, würde ich uns die Rollen Hersteller, Importeur und Vertriebspartner zuordnen.
Ist das richtig so? Ich bin mir unsicher, da unter der MDR die Definition der Wirtschaftsakteure anders ist.
Vielen Dank im Voraus.
Schöne Grüße,
Karl Heinz
Sehr geehrter Karl Heinz,
Ich sehe das genauso wie Sie: Sie scheinen Hersteller und Händler zu sein. Wenn das aber zusammenfällt, erübrigen sich die entsprechenden Forderungen der MDR weitestgehend. Ob Sie ein Importeur im Sinne der MDR sind, glaube ich eher nicht. Mir sieht es eher so aus, dass Sie einen ausgelagerten Prozess (Produktion) in Brasilien haben.
Beste Grüße, Christian Johner