US FDA 510(k) and EU CE Marking Medical Device Registration Strategy Training

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.

Topics

• US device classification
• US regulatory submissions strategy
• US pathways to market, including 510(k) premarket notification, De Novo, and PMA premarket approval
• EU CE Marking
• EU Directives (MDD, AIMD, IVDD) and EU regulations (MDR, IVDR)
• EU device classification
• EU conformity assessment routes
• Technical Files and Design Dossiers

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.

Related Courses

• New! EU MDR Transition Training (Europe’s Medical Device Regulation 2017/745)
• QMS Training for Medical Devices: FDA QSR and ISO 13485:2016