Medical Device Regulatory Affairs 101: Regulatory Affairs For Non-Regulatory Personnel
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?
Geared for both experienced medical device professionals as well as those new to the industry, this webinar is designed for those who need a better understanding of the regulatory requirements surrounding medical device development. It is also designed for those coming from the pharmaceutical or biotechnology worlds and now working on medical devices as well as those working on combination products. Scientists, engineers and technicians working on device design and development, product and product development managers, business development managers, marketing managers, QA/QC personnel, regulatory affairs professionals, investment and acquisition specialists, and field service engineers will all benefit from this webinar.
Michael Drues, Ph.D., is President of Vascular Sciences, an education, training, & consulting company offering a broad range of services to medical device, pharmaceutical & biotechnology companies. Dr. Drues received his B.S., M.S., and Ph.D. degrees in Biomedical Engineering from Iowa State University in Ames, Iowa, and has worked for and consulted with leading medical device, pharmaceutical and biotechnology companies ranging in size from start-ups to Fortune 100 companies. He also works on a regular basis for the U.S. Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the Centers for Medicare and Medicaid Services (CMS) and other regulatory and governmental agencies around the world. He regularly teaches graduate courses in Regulatory Affairs and Clinical Trials, Clinical Trial Design, Medical Device Regulatory Affairs and Product Development, Combination Products, Pathophysiology, Medical Technology, Translational Medicine and Biotechnology.