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Medical Waste Management
Expert holds a Master’s degree in Public Health from University of Connecticut and has been involved in the healthcare waste industry for over 21 years. His experiences cover all facets of the healthcare waste management arena from assessment of treatment…
Microbiology, Infection, Infection Control, Occupational and Hospital Hygiene, Biohazards, and Needlestick
Expert offers a highly valued research-driven consultancy specializing in healthcare, environmental, and occupational microbiology, waste management, and bio-safety. With a strong science-based research record in these areas, and a background in NHS and University Medical Schools, he has over 35…
Medical Devices; Product Development, Manufacturing, Marketing, Business Practices, Intellectual Property, Commercial Contracts, Corporate Finance, M&A
Global leader and serial entrepreneur in the medical device industry with multiple successes in building companies, teams, products, and revenues. Experienced at bringing new products to the world market in a high-growth dynamic environment. Experienced Board member and Chairman in…
Medical Devices, Patent Strategy, Patentability, Intellectual Property, Litigation Support
She has served as Vice President of Intellectual Property & Legal Affairs for The Sharper Image Corporation. In addition to focusing on patent strategy in several positions, she has lead and built R&D teams in both Class III medical device…
International and Domestic Medical Devices, Sales/Distribution, QA/RA Compliance
Expert thrives on overcoming the quality and regulatory hurdles in the most time-efficient and cost-effective manner possible. He speaks fluent FDA, MDD and ISO 13485 and can converse successfully in CMDCAS, PAL, TGA, SFDA and KFDA as well. Whether you're…
Hydrogel Science and Technology for Drug Delivery, Medical Devices and Consumer Products
Expert’s major contributions are in microbial control of wide range of medical devices and pharmaceuticals. He has a background in chemical engineering and polymer science. He has decades of experience from numerous companies- large device and pharmaceutical companies to startups…
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 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…
Medical Device Regulatory Submissions
She has extensive experience writing and compiling 510(k)s and PMAs for product clearance or approval with a well-established track record of success. Some of the device types she has experience include Surgical Instrumentation, Cardiac Ablation Systems and Catheters; Surgical, Ophthalmic…
Nanobiotechnology, Drug Delivery Platforms, Medical Devices, Targeted Therapeutics, Diagnostics
Expert has extensive experience establishing R&D operations in early stage biotechnology companies. He applied his knowledge in nano(bio)technology to develop innovative solutions to drug delivery and drug targeting challenges. His efforts to enhance the use of biomaterials in a variety…