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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
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;…
Reliability Engineering, Reliability Program Management, Accelerated Testing
Expert has conducted over 80 reliability program assessments in the high tech, aerospace, oil exploration, medical device industries. Expert has made high impact recommendations and guided design and manufacturing firms to make significant improvements in fielded product reliability, reducing warranty…
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…
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 Design and Analysis
He was responsible for providing product data for 510(k) submittals. He was responsible for developing devices and technology for patient gas monitoring devices, cardiac monitoring devices etc. He was responsible for the development of several defibrillators. He was responsible for…
Biomedical Engineering, Patents, Medical Device Design, Product Development, Eye Activity Devices
He has served as a consultant as well as trained and led numbers of team consultants in application software development projects for over 20 years. Masters Degree specializes in optics and diagnostic/remediative processes and devices based on eye activity. PhD…
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 Devices, In Vitro Diagnostics Design, Quality Control, Trouble-Shooting, etc.
Expert has authored and submitted 510(Experts for more than 25 IVD (In Vitro Diagnostics) products. These 510(Experts encompass a variety of IVD products from manual, semi-automated to fully automated non-isotopic diagnostic tests including point-of-care devices. Expert has the expertise to…
Development and Assurance of High-Assurance / Safety-Critical Software & Embedded Systems
Expert has substantial experience with software safety and reliability. Most of his career has been spent working with high-assurance systems and safety-critical software. He has developed software for commercial aviation systems, for medical devices, and for industrial controls and safety…