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Intro to Medical Device Submission - 510(k)s, PMAs & Exemptions

  January 22, 2018  
CfPIE - The Center for Professional Innovation & Education, Berlin, Germany
24 & 25 September, 2018

Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

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.  This course discusses 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 are also 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, and nanotechnology.

Using the case study, participants will learn to communicate more effectively with regulatory professionals and the FDA and understand how regulation impacts medical device development to get products to market quickly and efficiently and to avoid problems before they occur.

Organized by: Center for Professional Innovation & Education
Invited Speakers:

Michael Drues, Ph.D.

Specialties: Regulatory 

Michael Drues, Ph.D., is a medical technology and regulatory strategy consultant specializing in bringing medical products to market in creative and innovative ways and keeping them on the market once they get there. Dr. Drues received his B.S., M.S., and Ph.D. degrees in Biomedical Engineering from Iowa State University in Ames, Iowa. He 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.

Dr. Drues is an internationally recognized expert and featured keynote speaker on cutting-edge medical technologies and regulatory affairs. He conducts seminars and short-courses for medical device, pharmaceutical and biotechnology companies, the U.S. Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the US Centers for Medicare and Medicare Services (CMS) and other regulatory and governmental agencies around the world.

Finally, Dr. Drues is an Adjunct Professor of Medicine, Biomedical Engineering & Biotechnology at several universities and medical schools. 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.

Other Courses:


Deadline for Abstracts: N/A
Registration: https://www.cfpie.com/ProductDetails.aspx?ProductID=276
E-mail: info@cfpie.com
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