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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 Research and Development
Expert has over 30 years experience in medical device design dealing with all phases of design -- brainstorming, concept design, proof of concept testing, prototyping, cost / task estimating, project planning, project management, detailed design, bench testing, troubleshooting, design verification…
Biotech, Pharma and Medical Device Product and Process Development, Scale-up & Commercialization
His approach to process validation is that PV begins at the process development phase. A process that is well understood, well defined as per the critical to quality attributes with an understanding of the variable interactions prior to the definition…
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…
Durable Applications for Nonwovens, Quality Management Systems, New Business Development Systems
Has been responsible for global new business development for a leading international nonwoven manufacturer. Has lectured on the Stage Gate process of New Business Development at nonwoven association training course. Responsible for strategic planning for the North American Operations of…
Cleanrooms, Contamination Control, Ultrapure Media, Qualification and Validation, GMP, AMC
Expert has been active in aersol physics for more than 25 years. His PhD covers also the areas of environmental, indoor and cleanroom aerosols. He worked in a variety of scientific and technical projects covering the health effects of particles…
Centerless Grinding, Computer Controls, Automation Manufacturing, Tool Room Machines, etc.
He was involved with a lot of automatic loaders in a 4" length range and thought it could also be done with 8" long parts. He remembered a work rest his father had bought at an auction years before and…
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…
Overseas Sourcing of Components & Finished Goods, Electronics, Plastics, Fortune 1000 Companies
He has managed projects for an access control company and have supplied 2-3 different companies with access control products manufactured in China. Has sourced and managed several projects for companies in the CE audio field with volumes exceeding $5 million…