Der US-Markt gehört zu den wichtigsten Weltmärkten für medizinische Produkte. Alle Medizinprodukte, die in den USA vertrieben werden sollen, müssen die strengen Anforderungen der US-amerikanischen Zulassungsbehörde FDA erfüllen.
TeilnehmerInnen
+ Hersteller und Exporteure von Medizinprodukten
+ Dieser Basiskurs ist auch für TeilnehmerInnen ohne Vorkenntnisse oder mit geringen Vorkenntnissen geeignet.
Die Seminar-Inhalte
+ Legislativer und regulativer Überblick
– Überblick über die Gesetzgebung
– Organisation der FDA
+ Allgemeine FDA-Anforderungen
– Registrierung und Listing
– Einreichung
+ Zugang zum US-Markt
– Produktklassifizierung
– Investigational Device Exemption (IDE)
– Premarket Approval Application (PMA)
– 510(k) Premarket Notification
– Kennzeichnung/UDI
+ Postmarket-Anforderungen
– Medical Device Reporting
– Rückrufe
– Device Tracking
Weitere Seminare zu unserem USA-Schwerpunkt
+ Trendthemenkampagne USA: Qualitätsmanagement-Anforderungen in den USA (Quality System Regulation) am 4.11.22 ONLINE
+ Trendthemenkampagne USA: Medical Device Single Audit Programm am 2.12.22 in WIEN
Kosten für Mitglieder von LISA (Ecoplus, Human.technology Styria, LISAvienna, Life Sciences Tirol):
– EUR 290,- (exkl. USt.) pro Seminar
– EUR 646;- (exkl. USt.) für alle 3 Seminare
Kosten ohne Mitgliedschaft
Frühbucher (bis 4 Wochen vor dem Seminar): Euro 440,- (exkl. USt.)
Standard (4 bis 2 Wochen vor dem Seminar): Euro 490,- (exkl. USt.)
Last Minute (weniger als 2 Wochen vor dem Seminar): Euro 520,- (exkl. USt.)
– inkl. Seminarunterlagen als PDF und Teilnahmezertifikat
– Package für alle 3 Seminare: Euro 1.190,- (exkl. UST)
Ihre Trainerin
Cornelia Luban, Senior Consultant, Qserve Group Deutschland GmbH
Veranstaltungsort
Dieses Seminar findet in Wien statt. Wenn ein Präsenz-Seminar aufgrund von Einschränkungen nicht möglich sein sollte, wird das Seminar online stattfinden.
Bei Fragen wenden Sie sich bitte an
Lorenz Neuhäuser
e: lorenz.neuhaeuser@human.technology.at
t: +43 669 18899 706
Diese Veranstaltung finden in Kooperation mit en.co.tec Schmid KG, Ecoplus, Human.technology Styria, LISAvienna und Life Sciences Tirol) statt.
Die Veranstaltung ist kofinanziert durch LISA Life Science Austria.
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)
https://www.encotec.at/anmeldeformular/