January 2023

MedTech Impact Partners is led by Kwame Ulmer, a former FDA Director who spent over a decade evaluating medical technologies. MedTech Impact Partners assists MedTech companies from pre-series A to Fortune 500 and helps them get through the regulatory process and FDA.

Rook specializes in Quality and Regulatory strategies for early-stage medical device clientele, providing expertise in FDA regulations, MDSAP audits, ISO 13485:2016 compliance, and MDR conformity. Rook works with a wide range of devices, including class I-III devices, SaMD, and IVD.