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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,…
Valves, Control Valves, Piping, Pipe Couplings, Pipe Joining, Valve Testing, Valve Codes, and Standards
Expert, PE is an engineering consultant with over 35 years of mechanical engineering experience. Licensed Professional Engineer in NY and PA. Services provided include consulting and expert witness in the following areas: Product Safety Signs and Labels, Guards and Barriers,…
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…
Pumps, Electric Motors and Generators, Field Service, High Alloy, Temperature, and Pressure Control
Expert has been Operations Manager, Engineering Manager and Managing Director with single overall operation responsibility of a factory with 500 workers, where his team made electrical generators, synchrounous and induction specialties as rotary converters 50, 60, 400 Hz. The factory…
Medical Device Product Development; Machine Design; Biomedical Engineering
Medical device product development engineer. He performed research on adding an antimicrobial agent to a silicone rubber medical device molded using LIM. The research included materials, methods of molding, color changes, and effects on biocompatibility. His library contains many materials…