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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: 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: 732491 Washington, USA

Expert in Pharmaceutical Manufacturing, Combination Products, Medical Devices, and Good Clinical Practices

Expert is a retired Public Health Service (PHS) Officer with 16 years of FDA experience in Pharmaceuticals, Medical Devices, Biologics, and Bioresearch Monitoring. She has held the positions of Investigator, Pre-Approval Manager, Supervisory Investigator, and Foreign Inspection Cadre Member. She…

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: 729312 India

Expert in Regulatory Affairs/Registration Consultancy for Medical Devices/Drugs/IVDs/Food in Indian Market

Expert with a post graduate degree in Chemistry has been part of the team in the CDSCO, Government of India for framing of the Import Registration requirements for Drugs, Medical Devices and IVDs. Expert was the Medical Devices Reviewer for…

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…

Expert ID: 728303 California, USA

Expert in Medical Devices; Product Development, Manufacturing, Marketing, Business Practices, Intellectual Property, Commercial Contracts, Corporate Finance, M&A

Expert has been the CEO or chairman of seven medical device companies in four countries - four public, three private, and has been a member of the Board of Directors of 10 companies. He is an expert in areas of…

Expert ID: 726891 Wisconsin, USA

Expert in International and Domestic Medical Devices, Sales/Distribution, QA/RA Compliance

Expert thrives on overcoming the quality and regulatory hurdles in the most time-efficient and cost-effective manner possible. He speaks fluent FDA, MDD and ISO 13485 and can converse successfully in CMDCAS, PAL, TGA, SFDA and KFDA as well. Whether you're…

Expert ID: 726036 Minnesota, USA

Expert in 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…

Expert ID: 725331 California, USA

Expert in Medical Device Regulatory Submissions

She has extensive experience writing and compiling 510(k)s and PMAs for product clearance or approval with a well-established track record of success. Some of the device types she has experience include Surgical Instrumentation, Cardiac Ablation Systems and Catheters; Surgical, Ophthalmic…

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