Steve Jwanouskos
Principal Technical Advisor
As a regulatory and clinical consultant, Mr. Jwanouskos has more than 20 years of experience in the development of innovative medical technologies, including extensive expertise in the development of novel medical devices. He has managed both U.S. and international regulatory approvals and commercial application licenses for numerous medical devices. As project manager for MedClose™, Mr. Jwanouskos is responsible for guiding and overseeing the quality of all developmental, design and production work. Mr. Jwanouskos is an independent contractor and also provides CPC’s management team and board of directors with regulatory and commercial development counsel. Supporting Mr. Jwanouskos is a world-class team of technical experts, including:
- Sid B. Negus - Manufacturing Operations and Design Transfer, Independent Contractor
- Jill K. Irwin - Quality Manual & QSR, Irwin & Associates
James L. Rogers, Ph.D.
Bio-Statistician
Dr. Rogers is the founder and managing member of Summit Analytical, LLC, specializing in statistical analysis of clinical data supporting product approvals in the pharmaceutical and medical industries. He has extensive experience handling clinical data management, reporting results for peer-reviewed publications, and performing and reporting statistical analyses for leading US and European pharmaceutical and medical device companies. He also has served as a principal investigator and statistician on numerous privately and federally funded research grants. He has held appointments as a tenured professor at Wheaton College, Wheaton, Illinois and as a Senior Research Associate at Northwestern University's Department of Medicine. Dr. Rogers received his Ph.D. from Northwestern University, specializing in evaluation research. He has provided statistical evaluation for both comprehensive systems of healthcare and clinical programs to develop pharmaceutical agents, medical devices and nutritionals. Dr. Rogers is an independent consultant who will provide bio-statistical analysis for CPC of America, Inc. through Summit Analytical, LLC (Silverthorne CO), a statistical services company specializing in methodological consultation and statistical analytics to pharmaceutical, device and nutraceutical companies engaged in pre-clinical, clinical and post-approval trials.
Gerhard Frömel
Authorized European Representative
Mr. Frömel has more than 25 years of experience in medical research, development and regulatory affairs in the European Union. He has overseen clinical trials under the European Union’s Medical Device Directive and handled European regulatory affairs for a variety of international companies, including IVAC Corporation, Physio Control and three spin-offs of Eli Lilly. As CPC’s authorized European representative, Mr. Frömel will oversee all European Union requirements for CE marking related to MedClose™, including vigilance reporting, communicating with competent authorities in individual member states, assisting in securing international product registrations, and preparing and completing dossiers for clinical trials and CE markings. Mr. Frömel DIPL. Ing., is a member of several German and international standard organizations for medical equipment, including the DIN group which addresses safety and technical standards. He provides counsel to CPC of America, Inc. through Medical Product Service GmbH (MPS). Headquartered near Frankfurt, Germany, MPS is a European medical device consulting agency with more than 30 years of regulatory expertise in medical devices and surgical products. MPS represents the interests of more than 50 medical device clients chiefly in the U.S. and Asia.
Richard E. Anderson
Independent Consultant
Mr. Anderson is a quality assurance and regulatory affairs specialist with extensive experience establishing quality management systems for medical devices. For the past 30 years, he has worked with early-stage device companies to design systems that enhance the quality, productivity and efficiency of manufacturing. He has also worked with a variety of regulatory bodies, including the FDA and European Notified Bodies and Competent Authorities and has secured ISO and EN certifications. Mr. Anderson holds a Bachelor of Science in Quality Assurance, Summa Cum Laude from Cogswell College in Cupertino, California.
Lindsey A. Bronson
Quality Engineer
Ms. Bronson is a quality engineer with expertise in product development and regulatory compliance. She has overseen the successful development of numerous medical devices--from concept to launch--including cardiovascular devices. Ms. Bronson's expertise includes protocol development, design validation and verification, statistical analysis and ISO and FDA compliance. She holds a Bachelor of Science in Metallurgical & Materials Engineering from University of Idaho.