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Medical Device Development
BSME - Mechanical Engineer: 40+ years Medical Device design & development (13 patents) - Drug delivery devices, respiratory care devices, hemodialysis, and blood collection devices, in-vitro diagnostic instrument, and cartridge devices; 25+ years medical device product liability and patent infringement…
Engineering, Project Management, Corrosion Protection, Aluminium Metal Composites, Mechanical Material Corrosion
Expert is is an internationally recognized leader in the field of materials science and engineering with more than 27 years of independent research project management, teaching, and consulting. He has a blend of both industrial and academic leadership as a…
Medical Device Quality Assurance and Regulatory Compliance
Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…
Microelectronic components materials and reliability
Expert has 31 years of experience (the most recent 12 years in the position of Senior Scientist responsible for company analytical laboratories) at three companies manufacturing advanced semiconductor devices for military, aerospace, medical device, and other applications, and an additional…
Pharmaceutical Sciences (Small Molecules and Peptide Delivery), Novel Drug Delivery (Micelles, Liposomes, and Insitu Forming Gel), and Conventional Dosage Forms (Solid, Semisolid, and Liquid)
Expert is an experienced pharmacist with a demonstrated history of working in the pharmaceuticals industry. A skilled researcher, she is knowledgeable of R&D development in Pharmaceutics (small molecules), cosmetics and OTC (herbal products). Expert is experienced in industry and academic…
Medical Device Engineering
He worked on hazard analysis of medical devices such as biochemical sensors. He worked on packaging processes of medical devices such as implantable catheters. He worked on packaging materials of medical devices such as plastic packaging. He worked on manufacturing…
Medical Devices, Combination Products, Biotech, Pharma, R&D, Operations, Manufacturing, and Supply Chain
Experienced global leader of R&D, Technical Operations, and Manufacturing organizations. Industrial focus in Medical Devices, Small Molecule Pharmaceuticals, Biotech, Packaging/Labeling, and Combination Products. Broad functional experience in the fields of Project and Personnel Management, Logistics, Supply Chain, and Finance. Successful…
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,…
Cardiac Electrophysiology, Cardiology Drugs, Pacemakers, Defibrillators, Cardiac Medical Devices
Expert. Expert is a board certified cardiac electrophysiologist (cardiologist with expertise in the diagnosis and treatment of all cardiac rhythm disorders) with over 20 years experience as a clinical investigator, IRB Chair, and high volume implanter of cardiac rhythm devices.…
molecular modelling, QSAR, drug design, cytokine mimics, complex systems, nanotechnology, biomaterials, machine learning, AI, evolutionary methods
Expert has a PhD in radioastronomy and microwave spectroscopy and degrees in chemistry, chemical engineering, and physics. He is boundary-crossing, multi-skilled lateral thinker with unusually broad, highly relevant formal academic training in physics, chemistry, chemical engineering, and mathematics. He has…