PNP - Premarket Notification Process - 510k for US market | FDA (ENG)
Eendaagse bedrijfsinterne opleiding
The US Food and Drug Administration Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States.
This course discusses the FDA's regulatory authority for approving medical devices prior to marketing and the compliance programs used during the manufacture and post-marketing reporting systems. It also provides FDA strategies towards inspections of manufacturing sites, and compliance actions that may result from these inspections.
Resultaten
This course gives an overview of the regulations and policies set by the FDA for the pre-market approval, manufacture and post-marketing compliance of medical devices. The course will provide an understanding of the paths to obtaining agency approval, the type of controls, systems and documentation they expect to see in place, how the FDA performs inspections, and the variety of outcomes from each inspection.
Programma
Introduction to FDA:
- Classification of devices
- Premarket Notification 510(k)
- Premarket Approval (PMA)
- Establishment registration
- Medical Device Listing
- Quality System (QS) regulation
- Labeling requirements
- Medical Device Reporting (MDR)
- Managing FDA inspections at your company
Jouw coaches
Praktische informatie
Annulatievoorwaarden
Voor bedrijfsinterne projecten verwijzen we naar de algemene voorwaarden en de voorwaarden in de aangeboden offerte.
Nog vragen?
Heb je een vraag over deze opleiding? Wij helpen je graag verder! Neem gerust contact op met ons.
info@allanta.beGerelateerde
oplossingen
Wist je dat we onze advies en kennis op meerdere manieren inzetten? Ontdek hier aansluitende oplossingen.
Terug naar overzicht