Karl R. Leinsingis currently the President of ATech Designs, Inc., a Medical Device product development and consulting firm in North Carolina. Karl has Medical Device and automation experience since 1986. His areas of expertise include full life cycle product development of medical devices from conception through development including manufacturing, bench testing, verification, validation, packaging, labeling, clinical trials, regulatory approval, marketing, and sales training. 

Karl has anM.S. in Mechanical Engineering from North Carolina A&T State University and a Bachelor of Science Degree in Mechanical Engineering from the University of New Hampshire. He is a licensed professional engineer in New Hampshire and has lectured Medical Device and Manufacturing (MD&M) Seminars on The Science of Successful Product Design. He also has a Pilot License for Fixed Wing & Rotorcraft.

Karl has been granted 25 patents (others pending), his designs have been published by Life Magazine, was recognized as one of 100 notable people in the medical device industry by the Medical Device & Diagnostic Industry (MD&DI) publication in June 2008, and recently served as chairman of the Medical Device & Manufacturing Conference in 2014. 

He is the winner of 5 design awards for the SmartSite Valve - 1998 Medical Design Excellence Award (MDEA), 1999 NC Governors New Product Award, 2000 NSPE New Product Award, 2001 Prototype Design Award, and 2003 MDEA Gold Winner.

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Speaker: Karl R. Leinsing
Duration: 60 Minutes
Product ID: 700510

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FDA Chapter 21 CFR Subpart C Section 820.30 – Design Control Requirements

This webinar will discuss why certain steps are so important in the design process and that many steps are not just wasted time and paperwork. The process is a methodical approach that can be used more...