Kevin Morningstar has over 30 years experience in Regulatory/Clinical Affairs and Quality Assurance in the medical device industry. Prior to creating his own consulting practice in 1997, he held senior management, regulatory and engineering positions with ValveXchange, TomTec Imaging Systems, Ohmeda Medical Systems, Telectronics Pacing Systems and COBE Laboratories. He also co-founded Silverglide Surgical Technologies, Inc., a surgical instruments business successfully sold to Stryker Instruments in a planned exit. He holds a B.S. in Electrical Engineering from Michigan State.
Mr. Morningstar is also active in the Colorado startup and angel investor community.
Specialties: Medical device start-up, early stage medical device commercialization, international medical device regulations and standards, quality system architecture, process troubleshooting, design assurance, project management, design control, regulatory submissions, process validation and technical files.