Joe Schwoebel Email Address

Vice President, Clinical and Regulatory

Neuros Medical, Inc. a Cleveland, Ohio based neurostimulation company is focusing on developing neurostimulation therapies for unmet needs to patients worldwide

Expert in Medical Device Regulatory Affairs and Clinical Studies, including strategic plans, clinical protocols, and FDA submissions such as IDEs, PMAs and 510(k)s. Completed 12 multi-site clinical studies and obtained FDA release of over 100 products. Strong record of domestic and international regulatory success. With clinical studies, I developed clinical study plans, recruited investigators, obtained IRB approvals, enforced study compliance, prepared progress reports, and controlled budgets. From a compliance perspective, I implemented programs for Protection of Human Research Subjects, Good Laboratory Practices, cGMP/QSR (ISO 13485:2003), European Medical Device Directive, and Medical Device Reporting. Experience with pre-clinical biocompatibility studies, Class III implantables, transcutaneous devices and sterility assurance. Specialties: Cardiovascular devices, medical software, technology deployment, start-up challenges, strategic planning