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Medical Device Regulatory Support, Medical Device Registration, etc.
Expert is a Regulatory and Quality Consultant with strong team building skills for high technology corporations. A hands-on career of increasing leadership positions with a broad range of responsibilities in manufacturing, regulatory affairs and new product introductions. A committed professional…
Medical/Hospital Equipment: Markets, Unmet Needs, Concept, Design, IP, Automation, Manufacturing
Biomedical Devices range from simple items we use as consumers to complex instruments controlled by proficiently trained professionals. Expert's involvement and experience has been in the development of capital equipment that often included one or more disposables, were used in…
Opto-Mechanical System Design, Performance Modeling, Electrooptics, Lasers
He has extended expertise in advanced geometrical as well as wave optics as evidenced by years of successful optical design experience using industry-standard ZEMAX and OSLO optical design packages. Expert's experience in biomedical imaging is based on two years of…
Substance Use Disorders, Healthcare, Call Center Operations, Compliance, Quality Improvement, Strategic Planning, Mail Order, and Healthcare
C-SUITE EXECUTIVE Expert is a results-oriented, tested “C” class executive with extensive experience at driving the strategic direction and enhancing the operational functioning of organizations. Reputation for serving as the executive point of contact for all stakeholders, recommending data-driven change…
Quality System & Regulatory Compliance, Life Sciences, Re-Engineering, 21 CFR Part 11
Business system design, business process re-engineering, and business re-engineering are at the core of the expertise she offers her clients. She has designed, written, and implemented business-focused quality systems for start-up companies and well as provided re-engineering support for out…
Medical Device Marketing, Market Research, Competitive Analysis, Business Analytics, Medical Writing
Expert has over 12 years of marketing experience in the Class III and Class II medical device industry, specializing in new product launches, new product development, market research and marketing communications. She is highly skilled in analytics, research, tactical execution…
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…
Medical Device Design and Manufacture
Expert has over 25 years experience in the conception, design, and manufacture of medical devices. Experience ranges from high volume disposables to low volume implantables. Beginning as a manufacturing engineer responsible for all facets of device development and manufacture Expert…
Baby Diapers, Non-Woven, Absorbent Products, Films, Wipes, and Consumer Tissue & Towel
Has extensive experience in the development and evaluation of absorbent materials of all types for the management of all types of human exudates. This includes cellulose absorbent cores, superabsorbent materials, foams, fibers and non-woven absorbent materials. Has commercialized over a…
Commercialization of Scientific Devices, Inventions, Scientific Management Consulting, etc.
Expert has used his experience and knowledge of biochemistry and biophysical measurement to create tools for measurement of clinically significant targets for the biomedical industry. He has developed Drugs of Abuse and many other assays, supported the development of complex…