Summary

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Whether you are a new professional in the medical device industry or seasoned regulatory affairs and legal professional needing a refresher on current FDA medical device regulatory developments, you will benefit from this two-day interactive program. Hear from experts who will review the essential elements of Food and Drug Administration (FDA) medical device regulation in a systematic and comprehensive way.

Experts in the field will help you:

  • Focus on the broad legal framework of device regulation, FDA’s organizational structure and pre-market requirements.
  • Understand postmarket requirements, Quality System Regulation (QSR), adverse reporting, and advertising and promotion.
  • Understand key regulations and policies and differentiate how those regulations and policies are applied.
  • Prepare a successful 510(k) submission.
  • Identify new and developing FDA policies and procedures affecting all phases of medical device regulation.
  • Examine how FDA uses its statutory authority and some of the emerging issues in the ever-changing FDA regulatory landscape.

Who Should Attend

  • Medical Device sector of FDLI membership
  • Industry professionals working in regulatory and clinical affairs, research and development, operations and quality control, and management
  • Associates in law firms and other lawyers who have an interest in learning the medical device regulatory process
  • Personnel in legal departments at medical device companies, Contract Research Organizations (CROs) and other medical device focused organizations

This meeting can help you and your organization comply with FDA regulations, get products approved, and help minimize regulatory problems.