Global Medical Innovation Solutions (GMIS) is a management consultancy and regulatory outsourcing company with a focus on the U.S. market for medical devices. We provide both pre– and post–market regulatory solutions to help you receive U.S. FDA market clearance and approval and to help you remain in compliance thereafter. This includes services such as pre-FDA inspections and audits. Although we are located in Munich, Germany, we have a global network of regulatory and scientific experts th