Preparing Premarket Submissions that secures U.S. FDA Clearances/Approvals: 510(k)/Pre-IDE/IDE and PMA 2017

  • 27-28 Apr 2017
  • Courtyard Raleigh-Durham Airport, Morrisville, NC, United States

Description

Preparing Premarket Submissions that secures U.S. FDA Clearances/Approvals: 510(k)/Pre-IDE/IDE and PMA 2017 covers topics such as:

  • Title 21 Code of Federal Regulations (CFR) for Medical Devices
  • Food, Drug and Cosmetic Act (FD&C Act)
  • Premarket Approval (PMA)
  • Premarket Notification (510k)
  • Points to Consider for preparing a Successful Premarket Submission
  • Investigational Exemption Device (IDE)
  • Post Market Requirements of Medical Devices
  • Tips and Suggestions on interacting with FDA Officials

Preparing Premarket Submissions that secures U.S. FDA Clearances/Approvals: 510(k)/Pre-IDE/IDE and PMA 2017 brings together:

  • Marketing Professionals
  • Regulatory Affairs Professionals (associates, specialists and managers)
  • Quality Assurance and Quality Engineers
  • Research & Development - Product Managers
  • Buyers/Purchasing Professionals
  • Project Managers responsible for United States
  • Students majoring in Regulatory Affairs

Past Events

Important

Please, check "Preparing Premarket Submissions that secures U.S. FDA Clearances/Approvals: 510(k)/Pre-IDE/IDE and PMA" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: Healthcare
Industry: Food & Beverages

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