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  • A Comprehensive View of FDA Regulations for Medical Devices:
    2 - Day In-Person Seminar

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Tuesday - Jul 22, 2014 08:30 AM
  • End Time:
  • Wednesday - Jul 23, 2014 04:00 PM
  • Location:
  • Chicago,
    Illinois, United States
  • Course Description:

    Don’t let a common misunderstanding get you into trouble! There is more to the US Medical Device Regulations than Part 820.

    Companies that don’t understand will face regulatory scrutiny and receive FDA Form 483s and Warning Letters. Recently a device manufacturer got a Warning Letter relating to updates to shipped devices, which said, “The Quality Manager stated he was unaware of the corrections and removal reporting and recordkeeping requirements.”

    This two day interactive course on FDA regulations for medical devices will:

    - Cover more than just the Quality Management System
    - Provide an overview of regulations and how they fit together
    - Explain Unique Device Identification (UDI) in detail, covering the issues device manufacturers will face as well as timeline for implementation
    - Help attendees understand the four major elements of the US regulatory structure: laws, regulations, guidance, and consensus standards
    - Teach the current device marketing regulations
    - Discuss how to handle FDA inspections and effectively respond to inspectional observations and 483s
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