Course Date Upcoming Dates and Locations Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times. There are currently no public dates scheduled. All our courses are available to be held at a location of your choice. Please contact us for more information. In-Person Agenda▸ Virtual Class Agenda▸
Course Detail Objectives Identify the US FDA pathways to market as well as their advantages and disadvantages. Apply a strategy to choose an appropriate regulatory pathway. Describe how to establish substantial equivalence for a 510(k) premarket notification. Identify the necessary sections of a 510(k) premarket notification. Explain the role of the CE Mark in the EU. Describe EU device classifications and pathways to market. Identify the necessary sections of a Technical File. Identify the impact of the new EU device regulations (MDR and IVDR) and preparation challenges. Describe regulatory submission best practices. Who Should Attend Medical device quality and regulatory affairs professionals with a need to understand how to select an appropriate regulatory submission/clearance pathway for a medical device in the US and/or the EU. Virtual Half-Days 5 In-Person Full-Days 3 CEUs 2.5 In-Person Agenda▸ Virtual Class Agenda▸
Related Courses EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745) QMS Training for Medical Devices: FDA QSR and ISO 13485:2016 New! CER (Clinical Evaluation Report) Training for EU MDR Compliance