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Implantable and Non-Implantable Medical Device Risk, Safety, and Failures
He has experience in developing, writing, and submitting risk management related documentation to support Notified Body, 510k, PMA-S, and PMA submissions (Class I, II, and III). He has experience in the legal and safety requirements between 510k and PMA devices…
Medical Device Design and Analysis
He was responsible for providing product data for 510(k) submittals. He was responsible for developing devices and technology for patient gas monitoring devices, cardiac monitoring devices etc. He was responsible for the development of several defibrillators. He was responsible for…
Supply Chain Track & Trace (Pharmaceutical, Food, CPG). Highly experienced Consultant / Program mana
Expert specialized in the field of supply chain with particular emphasis on traceability of pharmaceuticals, medical devices, food and cosmetic from production to point of dispensing. He provides a Definition of a global strategy concerning supply chain optimization, track &…
Medical Device Research and Development
Expert has over 30 years experience in medical device design dealing with all phases of design -- brainstorming, concept design, proof of concept testing, prototyping, cost / task estimating, project planning, project management, detailed design, bench testing, troubleshooting, design verification…
Regulatory Affairs and Pricing and Reimbursement-European and Emerging Market
She has advised many International clients with regards to requirements for dossiers as well as routemap for ANDA Procedure in addition to the requirements for DMF dossier as well as routemap for EDQM Certificate of Suitability Procedure. She has worked…
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…
Plumbing, Piping, Fire Sprinklers, Hot Water Scalds, Water Damage, Product Defects, Water Heaters
Expert is a member of numerous ASME A112 Plumbing Product Standards Committees. Expert is also involved in the standard writing committees for hot water system temperature controls (mixing valves). He is an expert with Backflow Preventers, Instructor of Backflow Prevention…
Human Factors Engineering for Medical Devices and Software, Patient Safety
Expert has a PhD in Computer and Information Science with a major in artificial intelligence and minors in the theory of computation and cognitive science. His artificial intelligence worked included knowledge sharing and problem solving strategies for knowledge-based systems ranging…
Biomedical Engineering, Patents, Medical Device Design, Product Development, Eye Activity Devices
He has served as a consultant as well as trained and led numbers of team consultants in application software development projects for over 20 years. Masters Degree specializes in optics and diagnostic/remediative processes and devices based on eye activity. PhD…
Biostatistics, Epidemiology, Methodology, Mental Health, Police Procedures, Drug Safety, Malpractice
As a Professor of Statistics, Epidemiology, Public Health and Psychiatry for the last 30 years he has taught, applied and consulted on all of these methods. First trained as public health physician, he did his graduate work (MS and PhD)…