Janet Akil has 20 years of experience in the medical device industry working with both small and large firms. Prior to working for M Squared, Janet was Director of Regulatory and Clinical Affairs for Smith & Nephew Orthopaedics. Over the years, she has worked extensively with orthopaedic devices and with other types of medical devices and novel therapies. Janet’s leadership, strong writing skills, expertise in regulatory strategy development, and execution of submission strategies have supported numerous 510(k), IDE, PMA and HDE submissions. Her engineering background provides a unique perspective when developing preclinical test strategies used to support regulatory submissions and postmarket evaluations. As Senior Project Manager, Janet is involved in all aspects of regulatory & clinical strategies and works directly with FDA in coordination of correspondence and meeting preparations.