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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: 730278 Alabama, USA

Expert in Medical Device Sterilization, Medical Device QA, GMP Audit, Supplier Audit, SOP\’s

Expert, Consulting Principal, is highly regarded in the medical device and sterilization industries. Areas of expertise include: medical device sterilization (Radiation and EO), quality systems development and assessment, sterilization management, medical device regulations, supplier auditing, internal auditing, nonconformity investigation and…

Expert ID: 721133 North Carolina, USA

Expert in Medical Polymer Sterilization

MEDICAL POLYMER SELECTION; MEDICAL POLYMER STERILIZATION. With knowledge of material selection for medical devices, Expert has specific expertise in selecting materials based on cost, physical properties, radiation or other forms of sterilization, blood and tissue compatibility, permeability, and aging properties.…

Expert ID: 720664 New Jersey, USA

Expert in Medical Devices, Biotech, Aseptic Processing, Engineering, Facilities, and Sterilization

Expert has extensive expertise in all areas of aseptic processing and terminal sterilization of medical devices, human tissue for transplanation processing, microcontamination and controlled environments. He has been involved in clean room projects for Ethicon, Inc., Osteotech, Inc., Manufacturing Automation…

Expert ID: 717866 Virginia, USA

Expert in Sterilization, Biomaterials, Tissue Banking, Medical Product Development, Polymer Toxicology

Expert K. Expert has spent 30 years in the medical products business, in which he developed sterilization processes such as ethylene oxide, gamma radiation, vapor phase hydrogen peroxide, plasma sterilization, aseptic processing, disinfection with formaldehyde, glutaraldehyde, and steam sterilization. Novel…

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: 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: 733346 Connecticut, USA

Expert in Medical Device Regulatory Affairs: CE (Canada) and FDA

Expert has 25 years' experience in FDA, TGA, CE, and Health Canada product approvals for medical devices and combination devices. He has experience writing CER, CE applications, FDA applications, TGA and Health Canada applications. He has performed PMS, PMCF, recall,…

Expert ID: 731095 California, USA

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 ID: 727427 Canada

Expert in Electron Beam Equiment for Sterilizing Medical Devices, and Irradiating Foods, Polymers and Wastes

Expert is one of two partners in a consulting firm. He is the former General Manager of AECL Accelerators. He planned and led the team that developed Atomic Energy of Canada's high energy, high power electron beam technology. He set…

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