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Expert in Medical Device Quality Assurance and Regulatory Compliance
Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…
Expert in Medical Devices, Diagnostics, Digital Health
Expert has 20 years of leadership experience in medical device/life sciences marketing in small start-ups and Fortune 100 companies. Following an industry career Vice President of Marketing for Oridion (acquired by Covidien) Medical, Director of Marketing for Philips Medical, and…
Expert in Medical Device Engineering
He worked on hazard analysis of medical devices such as biochemical sensors. He worked on packaging processes of medical devices such as implantable catheters. He worked on packaging materials of medical devices such as plastic packaging. He worked on manufacturing…
Expert in 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…
Expert in Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and…
Expert in Medical Device Accidents, Surgical Fires, Oxygen Safety, Medical Gas Piping, Failure Analysis
Eng. Expert has been conducting medical device accident investigations for 25 years and product failure analysis for more than 30 years. These failures sometimes involve the actual failure of a metal, plastic, or glass part or a failure of the…
Expert in Medical Device Technology, Design and Manufacturing
Expert is a seasoned engineer with over 25 years of expertise in all aspects of medical device research, product and process development. His major areas of expertise include minimally invasive treatments of vascular disease as well as laparascopic and open…
Expert in Medical Devices; Product Development, Manufacturing, Marketing, Business Practices, Intellectual Property, Commercial Contracts, Corporate Finance, M&A
Expert has been the CEO or chairman of seven medical device companies in four countries - four public, three private, and has been a member of the Board of Directors of 10 companies. He is an expert in areas of…
Expert in Medical Devices
Expert is a medical device consultant and executive with more than 20 years experience in the medical device industry. His expertise spans all aspects of medical device commercialization, from medical device product development to medical device manufacturing and quality control;…
Expert in Electronics Design and Manufacture Reliability, Failure Analysis, Asia Manufacturer Risk Management
Expert has over 20 years of expanding responsibilities in the research and engineering of reliability risk identification, analysis, quantification and mitigation in the context of product and technology development. He is responsible for both technical and organizational leadership and technical…