FDLI - Introduction to Medical Device Law and Regulation

In this interactive two-day program, you will learn the essential elements of medical device regulations in a systematic and comprehensive way. The first day will focus on the legal framework, FDA’s organization and pre-market requirements and the second day will focus on postmarket requirements, the Quality System Regulation (QSR), adverse events, and promotion and advertising. The program will walk you through key regulations and policies, while it helps you develop a clearer understanding of how they work. You’ll receive an overview of the FDA regulatory structure, obtain pointers on how to prepare a successful 510(k) submission, and learn about new and developing FDA policies and procedures affecting all phases of medical device regulation. This program will help you to think like a seasoned medical device professional. Additionally, you will learn how FDA enforces the laws passed by Congress and some of the “hot” issues of the day. This meeting can help you and your organization stay in compliance with FDA regulations, get products approved, and help minimize regulatory problems.

Steve Niedelman will address "Quality Systems Regulation and Part 11".