Objectives
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Identify the US FDA pathways to market as well as their advantages and disadvantages.
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Apply a strategy to choose an appropriate regulatory pathway.
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Describe how to establish substantial equivalence for a 510(k) premarket notification.
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Identify the necessary sections of a 510(k) premarket notification.
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Explain the role of the CE Mark in the EU.
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Describe EU device classifications and pathways to market.
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Identify the necessary sections of a Technical File.
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Identify the impact of the new EU device regulations (MDR and IVDR) and preparation challenges.
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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.
Number of Days:
3
CEUs:
2.5