Reedhook Consulting is an independent consultancy providing executive-level leadership in early-stage regulatory and clinical development for a diverse portfolio of venture-backed and privately funded startup medical device clients. We provide strategic input on regulatory strategy and submissions, preclinical and clinical study design and execution (U.S. and international), system optimization, EDC database design and validation, and data analysis and reporting. Principal Laurie Hook has authored successful IDE, 510(k), and PMA submissions to the FDA as well as CE Mark submissions in the EU; designed and successfully executed multiple U.S. and international investigational and post-market clinical trials; designed multiple statistical analysis plans; and authored clinical reports.
