Talk to the FDA Before You Talk to the FDA MedTech Impact Partners is led by Kwame Ulmer, a former FDA Director who spent over a decade evaluating medical technologies. After leading regulatory affairs and quality assurance at a multinational medical device company, Kwame began partnering with companies to quickly determine the most efficient way for a product to enter the market. Kwame uses these insights to assist companies from pre-series A to Fortune 500 and helps them get through the regulatory process and FDA. This includes but is not limited to: -Full cycle submission oversight -Custom regulatory strategy on demand -Full prep for pre-submission meetings -FDA application review Schedule a call to explore how we can get your product to market faster.