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Expert ID: 723903 North Carolina, USA

Expert in Medical Device & Pharmaceutical Quality Systems; Regulatory. Affairs; Quality Fitness Reviews

Advised and trained Operations and QA employees in a large pharmaceutical plant on effective practices to investigate and document deviation events on the manufacturing floor and quality control laboratory. The aim of such investigations was to determine a root cause…

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: 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: 732167 Maryland, USA

Expert in Healthcare Technology, Medical Devices, Clinical Engineering, Biomedical Engineering, and Hospital Technology

Expert is an Expert Consultant for hospitals, medical device companies, legal firms, and insurance carriers. Responsibilities consist of providing biomedical, clinical, and forensic engineering support to clients, that can include incident investigations, reports of findings, as well as expert witness…

Expert ID: 730258 California, USA

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 ID: 729915 Texas, USA

Expert in wound healing, burns, clinical research, FDA regulations, drugs, devices, medical writing

Expert provides scientific knowledge and regulatory background to assist companies in the research and development of clinical, animal and laboratory studies designed to promote pharmaceutical drugs and medical device products specializing in wound healing and burn care. Additional Services: •Development…

Expert ID: 729827 Pennsylvania, USA

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 ID: 729752 New Jersey, USA

Expert in Medical Device Design Control and Software Validation

Expert has extensive medical device engineering development and regulatory experience. He is a certified Lloyds of London ISO 9000 Lead Auditor and a member of the Westlaw Roundtable Expert Witness Network. His regulatory experience is primarily in product development, design…

Expert ID: 729566 Illinois, USA

Expert in Food & Drug Administration Rules, Policies, Procedures for Medical Devices and Pharmaceuticals

Expert is an FDA compliance expert with 28 years experience in the field. He served the U.S. Food and Drug Administration as an Investigator concentrating in compliance for pharmaceuticals and medical devices as well as pre-market development of drugs and…

Expert ID: 729236 California, USA

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…

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