july, 2015

14jul8:00 am3:00 pmFDA 101 – Medical Device Regulations for Non-Regulatory Professionals


Event Details

Geared for both experienced medical device professionals as well as those new to the industry, this seminar is designed specifically for those who need a better understanding of the regulatory requirements necessary to bring medical devices to market in the US and around the world. This unique seminar demonstrates important regulatory requirements and concepts using case study discussions of real products from a variety of clinical specialties. Strategies for using regulation as a competitive advantage will also be discussed.

All medical device pathways to market are presented with a discussion of the advantages and challenges of each.  Multiple examples of products on the market, under development and on the drawing board (including videos!) are presented in an interactive format. The seminar concludes with a look at the regulatory challenges for the future of the medical device industry including combination products, tissue engineering, nanotechnology and beyond!

Using the case study approach, participants will gain a working understanding of:

  • What is and is not a regulated medical device?
  • How are medical devices classified and how can you use classification to your advantage?
  • What are the different pathways to market and how do I decide when to use each?
  • What does the future hold?

In this seminar, participants will learn to communicate more effectively with regulatory professionals and understand how regulation impacts medical device development to get products to market quickly and efficiently and to avoid problems before they occur.


(Tuesday) 8:00 am - 3:00 pm


Boston Location

Boston, MA