Course

Regulation of in vitro Diagnostics in Europe and the US

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This course offers a comprehensive overview of the current European and U.S. Regulatory and Quality Affairs for in vitro diagnostic (IVD) products. You will gain a perspective on the critical elements of the regulatory requirements for obtaining IVD marketing approval. This course will take an extensive look into specific in vitro diagnostics topics and learn about the new and emerging regulatory requirements surrounding them. Learn about the impending transition for IVDs from the current European Directives (IVDD) to new substantially different European Regulations (IVDR), which will bring a majority of currently self-declared IVDs to require Notified Body involvement. Skills needed: "Quality Systems for Medical Devices: FDA QSR and ISO 13485" or working knowledge/experience in Quality Systems is needed.