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Michael Thomas RAC
Director, Regulatory Affairs
Innovasis Inc
Michael is currently serving as the Director of Regulatory Affairs at Innovasis, Inc. which manufactures over two dozen product systems for the lumbar, thoracic, cervical, and cranial regions. He has been the author or co-author of numerous 510(k)s and other market authorization submissions, bringing new products to market through collaboration with regulators. Michael’s experience is primarily focused on the U.S. market but has also supported CE certification and withdrawal processes in response to the EU MDR and helped transition his company's QMS for multiple significant changes, including but not limited to ISO 13485:2016 and the MDSAP audit model. He has also supported post-market surveillance processes for multiple product lines in the U.S., Australia, Brazil and Canada. Innovasis also proudly supports a humanitarian program in Peru, which treats spinal pathologies in underprivileged communities.
Michael has a B.S. in Sociology from the University of Utah, holds the RAPS RAC credential for Medical Devices and holds multiple certifications for medical device manufacturing. He also serves on the board of the Orthopaedic Surgical Manufacturers Association (OSMA).
Michael has a B.S. in Sociology from the University of Utah, holds the RAPS RAC credential for Medical Devices and holds multiple certifications for medical device manufacturing. He also serves on the board of the Orthopaedic Surgical Manufacturers Association (OSMA).
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