Without a solid understanding of the regulatory requirements surrounding medical device development, non-regulatory professionals are not thoroughly prepared for how the process can impact clinical trials, approvals, and go-to-market strategy. Understanding how regulations impact device development (and learning to communicate more effectively with regulatory professionals) will help avoid problems before they occur.
This seminar will demonstrate important regulatory requirements and concepts using case study discussions of real products from a variety of clinical specialities. 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. Strategies for using regulation as a competitive advantage will be discussed.
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?
- What are the different pathways to market and how do I decide when to use each?
- What does the future hold?