Gerald M. Marshall, Ph.D., is a highly respected international consultant, speaker, and author with extensive experience in medical device development, quality assurance (QA), and regulatory affairs (RA). He specializes in guiding medical device companies through complex regulatory landscapes, including FDA requirements (e.g., 21 CFR Part 820), ISO 13485, and CE marking. Dr. Marshall is known for his practical approach to implementing effective quality management systems, risk management, and design controls. He has authored several influential textbooks and articles that serve as key resources for professionals in the biomedical and medical device industries, focusing on topics like clinical pathology, quality systems, and regulatory compliance.
Gerald M. Marshall's work history includes a series of influential roles in various companies. Here is a detailed list of his professional journey:
Authored and co-authored several widely recognized textbooks and reference materials on medical device quality systems, regulatory affairs, and clinical pathology, such as 'Marshall's Clinical & Experimental Pathology' and books on FDA/ISO compliance, which are used by professionals and academic institutions worldwide.
Established a long-standing reputation as a leading expert and consultant in medical device Quality Assurance and Regulatory Affairs, successfully assisting numerous companies in achieving and maintaining compliance, product approvals, and implementing robust quality management systems.
Frequently invited to speak at international conferences and conduct training workshops on topics related to medical device regulations, quality management, and risk management, sharing his expertise with a global audience of industry professionals.
The University of Texas at Austin
University of Pennsylvania - The Wharton School
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