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wound healing, burns, clinical research, FDA regulations, drugs, devices, medical writing
Expert provides scientific knowledge and regulatory background to assist companies in the research and development of clinical, animal and laboratory studies designed to promote pharmaceutical drugs and medical device products specializing in wound healing and burn care. Additional Services: •Development…
Medical Device Technology, Clinical Research & Business Development
Expert has decades experience in Multi-modality medical imaging: digital x-ray, ultrasound, IVUS, MRI, intra-operative MRI, multi-slice and cone beam computed tomography, hybrid PET/CT and SPECT/CT, optical coherence tomography (OCT), endo-confocal microscopy and fluoroscopy imaging. Furthermore, he has experience in Image-guided…
Lean Manufacturing and Operations
As Principal of his process improvement firm, Expert provides practical and realistic support for business improvement efforts. He offers over 40 years' hands-on international experience in a variety of industries -- including Dental Labs, Medical Devices, Clinical Research, Electronics, Aerospace,…
Scientific, Clinical, Medical, and Regulatory Affairs
Expert is a senior executive and a global biomedical leader with expertise in all facets of basic, pre-clinical, clinical research, and regulatory science for drug, biologic, therapy, vaccine, and medical device development. Expert is a leader in strategic planning and…
Physics, Mechanical Engineering, Medical Device Product Development, Blood Collection for Diagnostics & Therapeutics, Patent Litigation Expert Witness
Expert is Founder and Principal Consultant at a consulting firm founded in 2015, focused on industrial mechanical engineering and research and product development, in medical devices, diagnostics, optical, imaging, and laser devices, point-of-care blood sample testing, and on expert witness…
Orthopedic Surgery and Orthopedic Device Regulation
Expert did his undergraduate and medical school at the University of Michigan, an Alpha Omega scholar. His internship and residency were at the University of California at Davis, where he was an outstanding resident of the year on two occasions.…
Biomechanical Engineering
Expert is a bioengineer, a discipline that applies mathematics, physics, and engineering technologies to the study of biology and medicine with a focus on human health. He is the owner and principal investigator of a business entity recognized by federal…
Nephrology and Managed Care
Experience: Chief Medical Officer, Chief Health Officer, Chief Value Officer, Value Creation, Medical Operations, Healthcare Strategy, Complex Medical Conditions, Total Cost of Care, Affordability, Real-World Value Evidence and Outcomes Research, Medical Devices, Healthcare technology, Pricing and Market Access, Value Based…
Operating Room, Sterile Processing, and Surgical Practices
Experienced clinical leader with a successful record of leadership, experience and achievements advising medical device manufacturers, developing and implementing field-based sales/product training for sales reps, corporate clinical training, and continuing education workshops for medical/hospital staff and surgeons. Expert in Operating…
Pharmaceutical Science; Preformulating, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation
As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal conditions for…