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David M. Makanani
Vice President, Regulatory Affairs, Quality Assurance, Clinical Affairs
David Makanani is the co-founder, Director, President and Chief Executive Officer of Inavonx, inc. and has extensive experience in managing the development and marketing of high technology medical devices. . In 2002, Mr. Makanani and Mr. Ford formed a medical device-consulting firm, OMEDtech, LLC. which specializes in regulatory affairs, product development and operations management.
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In 1999, Mr. Makanani joined SOUNDTEC, Inc., a start-up medical device company that is actively marketing a successful implantable middle ear hearing system for moderate to moderately severe hearing loss, as VP Clinical and Regulatory Affairs and was key in the company’s fast track PMA product approval. Mr. Makanani served as the V.P. of Clinical and Regulatory Affairs with BioTronik, a developer of state-of-the-art pacemaker technology. Mr. Makanani served as the Director of Regulatory Affairs for Sulzer Carbomedics and played a key role in the successful approval of the company’s first heart valve. Mr. Makanani served as the Director of Clinical Programs for Amnion, Inc. a start-up company developing an Autologus Blood Recovery System. Mr. Makanani was the Manager of Corporate Regulatory Affairs for Intermedics, Inc., a start-up medical device company focusing on the then new pacemaker technology. Prior to his industry experience, Mr. Makanani served as a Medical Device Specialist for the Food and Drug Administration.
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