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FDA Reports of Corrections and Removals for Medical Devices



 
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Product Code: WB5
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About the Product
Contains video file.

The Reports of Corrections and Removals (C&R) regulation is concerned about what firms do about problems identified through Medical Device Report (MDR) regulation and the Quality System Regulation (QSR). These regulations create a foundation for risk management that is central to FDA’s regulatory concerns, particularly for C&R. The seminar will include the following postmarket regulatory issues:
  • Purpose of the regulation
  • Parallel concepts with MDR and voluntary recalls concerning risk to health
  • Key sections of the C&R regulation
  • Enforcement
  • C&R as part of a interdependent regulatory system for devices

Speaker
:
Casper E. Uldriks, JD, MDiv.
Associate Center Director Regulatory Guidance and Government Affairs
Center for Devices and Radiological Health

FDA


The session summarizes the same information that has been used to train FDA investigators.

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