SDRAN: A Window into the Changing Landscape of FDA Drug Effectiveness Standards

Online Webinar

A Window into the Changing Landscape of FDA Drug Effectiveness Standards   Program Speaker: Frank Sasinowski Director at Hyman, Phelps & McNamara, P.C.   Wednesday, March 17, 2021   Event Agenda: DATE: Wednesday, 17 March 2021 TIME: 6:00 – 6:05 PM Welcome and Announcements 6:05...

After Brexit: The New UKCA and UKNI Marks. What Medical Device Manufacturers Need to Know

Online

Brexit is now over and as of January 1, 2021, medical device manufacturers are officially in a transition period until June 30, 2023. However, you must understand the current requirements for UK MHRA registration, obtaining the services of a new UK Approved Body, and working toward affixing the new UK CA or UK NI mark on medical devices entering Great Britain. Further, UK MHRA will not be utilizing the EU MDR or EU IVDR after the transition period but drafting brand new legislation for their new Medical Device/IVD approval scheme. While everyone is focused on the EU – do not forget the Great Britain market and these new requirements.

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