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Regulation, Clinical and Software for Medical Devices

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November 5 - 7, 2024
The Royal Sonesta Minneapolis DowntownMinneapolis, Minnesota

James Kleinedler
Director of Regulatory Strategy at Medtronic
Speaker

Profile

Jim Kleinedler is the Director of Regulatory Strategy in Medtronic’s Global Regulatory team where he serves as a strategic resource for innovative programs across the product lifecycle. Dr. Kleinedler joined Medtronic from Boston Scientific, where he drafted IDEs, 510(k) and PMA submissions and worked with regulators to align on strategies with a focus on IRB/EC submissions, early feasibility studies, and breakthrough device designations for emerging interventional cardiology technology. He is a former FDA device reviewer, where he led premarket review of Class II & III cardiovascular device applications and served as a biocompatibility focal point within CDRH. Dr. Kleinedler earned his B.S. in Chemical Engineering from Iowa State University, and Ph.D. in Toxicology from LSU. He is the author on 10 peer-reviewed publications, inventor on seven medical device patents, and is an adjunct professor at St. Cloud State University’s graduate program in regulatory affairs.

Agenda Sessions

  • Pre-submission, or no Pre-submission, that is the Question

    4:00pm