FDA Medical Device Regulation for the Beginner 2012

  • 20 Apr 2012
  • Webinar

Description

FDA Medical Device Regulation for the Beginner 2012 is a webinar that covers topics such as:

  • Statutory and Regulatory Authority
  • Organizational Structure
  • Class I Medical Devices, 510(k) Premarket Notification and Premarket Approval
  • Medical Device Classification System
  • The Components of a 510(k) Premarket Notification
  • The Process for Bringing a Medical Device to Market in the U.S
  • User Fees
  • A Manufacturer`s Responsibilities
  • An Introduction to the Quality System Regulation (21 CFR Part 820)
  • Labeling and Promotion
  • Inspections
  • The Import / Export of Medical Devices
  • FDA Enforcement Activities

FDA Medical Device Regulation for the Beginner 2012 brings together:

  • Managers
  • Regulatory Affairs Professionals
  • Scientists
  • Consultants
  • State Policy Officials
  • Research Analysts
  • Investment Analysts and Venture Capitalists
  • Insurers focusing on Representations & Warranties Insurance
  • Financial analysts and investors watching the life sciences industries
  • Medical Device and Biotech Companies, Start-ups, Foreign Manufacturers, Importers, Labelers, Pharmacists, Convenience Kit Manufacturers

Past Events

Important

Please, check "FDA Medical Device Regulation for the Beginner" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Medical device
Technology: Biotechnology

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