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Medical Device Failure Analysis, Medical Device Product Liability, Patent Infringement Analysis, Patent Invalidity and Validity Analysis, Patent Claim Construction
Expert has over 20 years in the medical device and electronics industries, with contributions exemplified in the numerous products that were developed under his leadership. These products today are improving the quality of healthcare, in hospitals, sub-acute and alternate care…
Medical Devices and Plastics
Expert has been recognized frequently by upper management for his contributions to groundbreaking product development and launch of medical devices. He has over 24 years of engineering consulting experience in the design and manufacturing of medical devices and FDA investigation…
Process Improvement, Virtual Process Validation, and Discrete Event Simulation
Expert possesses more than 25 years of experience working in industries of different segments (metal mechanic, polymers, rubber, automotive and machining). Combined with his depth of lean process experience, Expert has specialized himself planning and implementing new processes and performing…
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,…
Medical Devices
Expert has about 10 publications on ablation. He published papers on this area and had grants to develop radio-frequency cardiac and liver ablation systems. He founded and directed a laboratory for medical device testing under IEC standards. Overview of Skills:…
Consumer and Medical Product Development, Structural Analysis and Design for Manufacturing
This expert's fingerprints are on many successful products - from satellites orbiting in space to tiny surgical instruments in the operating room. He has contributed to a wide range of product categories including automotive, office, as seen on TV, consumer…
Lasers and Electro Optics
Provide R&D, engineering, application, product development, 3rd party technical/service, employee training, due diligence research, safety and regulatory compliance of lasers. electro optics and light based instrumentation. As a laser and electro optic technology specialist I’ve been an ongoing engineering, application,…
Sterile Processing, Team Building, Department Collaboration, Standardizing, PI, and Change Management
Expert is a diversely skilled Sterile Processing executive with over 34 year’s medical experience. Among other achievements, she has established department SOP -- and implemented, demonstrated and mastered LEAN processes. She eradicated IUSS -- formerly flash sterilization. She has also:…
Medical Devices – ENT Devices, Surgical Devices, Cardiac Devices, Renal Devices & Artificial Organ
Expert has over twenty years experience in designing and developing medical device to clinical problems. Also, he has extensive experience as a surgeon having performed ENT head and neck surgeries and assisted in neuro surgeries and other general surgeries. He…
Medical Product Design and Development
I have nearly 20 years professional experience with product development and manufacturing. This is ignoring the extensive experience I gained in my own time beginning at a very young age. For example, by age 10 I was experimenting with lasers…