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Medical Device Regulatory Affairs: CE (Canada) and FDA
Expert has 25 years' experience in FDA, TGA, CE, and Health Canada product approvals for medical devices and combination devices. He has experience writing CER, CE applications, FDA applications, TGA and Health Canada applications. He has performed PMS, PMCF, recall,…
Hydroelectrics
Expert is Senior Executive Project Engineer and former Senior Vice President of a hydro power company. He has over 40 years of experience on dam, hydraulic, heavy civil and mechanical, hydroelectric, pumped storage, & water resources projects. He has served…
Acute Wound Healing, Animal Models, Re-epithelization, Wound Infection, Burn Wound Healing, Bacteria
Expert and her mentor, David Taplin were the first to identify flower water as a potential source of hospital acquired bacterial infections. She also worked on and helped develop a medium that has a color indicator to detect dermatophytes. She…
Addiction Medicine, Chronic Wound Management, Lymphedema, Vascular Medicine, Pain Management
As a full time, certified wound care specialist for almost 22 years and with a background in General and Vascular Surgery, Expert is trained to deal with all aspects of the field of wound care. This would include all aspects…
Internal Medicine, Diabetes, Advanced Wound Care, Hyperbarics
Expert has board certification in Internal Medicine and Advanced Wound care with at least 5 yrs in wound care. He is a full time physician as well as an assistant professor at an affiliated university. He has applied his medical…
Wound Healing, Cell Biology, Molecular Biology
Expert has been involved in studies of angiogenesis for many years. He demonstrated the important role of macrophages in mediating angiogenesis in wound healing and inflammation. His studies of the angiogenic factors produced by macrophages has led to a deeper…
Registration of Drugs, Medical Devices, Cosmetics,Borderline Products; Reimbursement, expert witness
Expert has more than 30 years experience in the registration of ethical and OTC pharmaceuticals. He has worked with solid dosage forms, aerosols, sterile injectables, vaccines, topical products, and biotechnology products. He has registered new chemical entities, novel dosage forms,…
Biomedical Device Engineering
BIOMEDICAL PRODUCT DEVELOPMENT; MEDICAL DEVICE PRODUCT DEVELOPMENT; NEW PRODUCT DEVELOPMENT. Expert has dedicated his career to the research, design, development, engineering, and manufacturing of biomedical devices and instruments. Expert has directed medical device new product development projects and a product…
Wound Healing, Combat Casualty Care, Hemostasis, Collagen, Pressure Ulcers, and Keloids
Expert's laboratory at The Wound Healing Center and the Laboratory of Tissue Repair has expertise in a variety of areas related to wound healing, tissue repair, chronic non-healing ulcers, and fibrosis. He and his staff have designed experiments to test…