Medivice Consulting, LLC
Biotechnology - New Durham, New Hampshire, United States
Medivice Consulting, LLC Employees
Medivice Consulting, LLC Details
Medivice Consultring provides advice on clinical and regulatory strategies for in vitro devices (IVDs) with emphasis on oncology and cardiovascular diseases. With 25 years of industry experience and 16 successful FDA submissions, half of those for "new to the world" assays, we are experienced in the conception, design and management of pilot studies and pivotal clinical trials. We also create and manage 510(k) and PMA submissions, the pre-IDE process, as well as IDEs. We have managed Companion Diagnsotics and Combination Products. We have experience with Humanitarian Use Devices, Laboratory Developed Tests, Analyte Specific Reagents and RUO/IUO assays. In additon to clinical trials and reglatory submissions, we write and submit manuscripts to peer-reviewed journals. We also have extrensive experience in recruiting thought leaders to Advisory Boards, and designing, managing and leading Advisory Board meetings.
