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Expert ID: 736123 Indiana, USA

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 ID: 735392 Virginia, USA

Expert in Biomaterials, Biotechnology, Medical Devices, Polymer Chemistry, Biomedical Engineering, Materials Engineering, Healthcare (regulatory), Intellectual Property Strategy

Expert has more than 20 years experience in biomaterials and medical devices, both in industry and as a university professor performing research. His research has a translational focus, so he has conducted numerous pivotal animal studies related to the fields…

Expert ID: 735921 Georgia, USA

Expert in Medical Device Quality Assurance and Compliance, FDA Medical Device Regulations, Quality Management Systems, Lean Six Sigma, Certified Six Sigma Master Black Belt

Expert is an extensively knowledgeable, self-motivated, and result-oriented Biomedical Engineer with an extensive background in quality and reliability engineering. Interested in verifying and validating solution designs, including detailed quality metrics in maintaining quality management systems that support and improve processes,…

Expert ID: 732325 Minnesota, USA

Expert in Medical Devices, Business Development, Regulatory Affairs, Project Management

Expert successfully launched over 25 new instrument and disposable medical devices. He developed and managed numerous cross-functional and cross-cultural new product and process teams. He has developed rich experience in team leadership and assembly, grounded in RA/QA fundamentals (RAC Certified).…

Expert ID: 733758 Missouri, USA

Expert in Medical Device Failure Analysis, Medical Device Product Liability, Patent Infringement Analysis, Patent Invalidity and Validity Analysis, Patent Claim Construction

Expert has over 20 years in the medical device and electronics industries, with contributions exemplified in the numerous products that were developed under his leadership. These products today are improving the quality of healthcare, in hospitals, sub-acute and alternate care…

Expert ID: 732824 California, USA

Expert in Medical Devices and Plastics

Expert has been recognized frequently by upper management for his contributions to groundbreaking product development and launch of medical devices. He has over 24 years of engineering consulting experience in the design and manufacturing of medical devices and FDA investigation…

Expert ID: 733859 Arizona, USA

Expert in Manufacturing technologies for Pharmaceuticals, Biologicals, Biotech and Vaccines

Expert is an independent consultant to bio-pharmaceutical, medical device and vaccine manufacturers, associated equipment suppliers and investors, with over 40 years experience in aseptic process technology, new product and business development, marketing strategy and regulatory compliance for manufacturing of pharmaceuticals…

Expert ID: 733713 Texas, USA

Expert in Sterility Assurance Expert in terminal sterilization (Ethylene Oxide, Moist Heat, Radiation, Dry Heat) and Aseptic Processing to Medical Device and Pharmaceutical companies.

. Expert is President and Principal Consultant for his consulting company - a consulting LLC. Prior to going into consulting, he was Director of Corporate Quality Technology/ Sterilization Science, for Alcon a Novartis company where he was responsible for sterilization…

Expert ID: 734924 California, USA

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 ID: 734908 Georgia, USA

Expert in IT: Software Consulting, Manufacturing and Supply Chain (Warehouse and Inventory) Management and Traceability, and CGMP

Expert is an operationally focused, multi-disciplined, senior IT professional specializing in the installation and/or project recovery of complex/multi-dimensional manufacturing and supply chain-related systems and equipment. He is highly technically and operationally but with the abilities experiences, and temperament needed to…

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