Dennis Crane, the Vice President of Clinical and Regulatory Services, partners with clients to fulfill their needs related to clinical studies and regulatory submissions. In this role Dennis develops strategies for clinical studies in addition to executing the studies and documenting the results. His clinical responsibilities cover both pre-clinical and clinical studies. He also develops strategies for regulatory submissions in addition to executing product approval submissions in the US and internationally.
His expertise includes US and international clinical studies designed to provide support for regulatory approval and post-market studies designed to support market penetration and to support reimbursement.
Dennis has over 26 years of experience in the medical device industry. He has worked at both start-up and established market leading companies in multiple capacities including clinical research, regulatory affairs and quality systems. His hands-on experience has provided him with expertise in US and international clinical trial design and execution including pre-clinical and post-market studies. His track record includes successes in the US, European, and Latin American markets. Additionally, he has successfully obtained 510(k), IDE, and PMA approvals; Competent Authority; and CE Mark approvals.
Dennis holds a bachelor’s degree in biomedical engineering from Case Western Reserve University, Cleveland, OH. He has been a presenter at various industry alliance programs.