Published Date: June 16, 2023
Ensuring compliance looks different depending on what phase you’re in (e.g., pre-market, post-market, or somewhere in between). In this webinar, one of our experts, Dr. Stephen Coulter, Ph.D., from Regulatory Compliance Associates (RCA) discusses how to prepare a device master record (DMR) to comply with FDA regulations.
Learn more about the presenter below.
General Manager and Subject Matter Expert | Regulatory Compliance Associates
Dr. Stephen Coulter is the General Manager and Subject Matter for Nelson Labs company Regulatory Compliance Associates (RCA), bringing over 40 years of experience to his role. His areas of expertise include product development, design control, design transfer to manufacturing, technology partnerships, product lifecycle management, portfolio management and acquisition analysis. Steve's regulatory affairs and quality assurance experience includes preparation of design history files or technical files for regulatory submissions. He has also participated in company advocacy efforts with federal agencies, congressional personnel, and public health groups.
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