As the president and managing partner of MethodSense, Inc., I lead a life science consulting firm that guides medical device, biotech, and pharmaceutical companies with regulatory, quality, and technology solutions. With over 20years of experience in this role, I have developed a deep expertise in compliance operations, business development, customer support, and strategic alliances.My mission is to enable our clients to operate more effectively during the commercialization process and beyond, by delivering FDA submission support, quality system development, process and validation strategies, audits, software optimization, risk remediation, and standards expertise. I have successfully managed multiple projects involving 510(k) submissions, medical device technology validation, safety testing and certification, and SDLC management. I also serve as a member of the Coulter Translational Research Program Oversight Committee, where I assist in selecting, monitoring, and mentoring biomedical innovation projects.