Prof. Moustafa M. Mohamed Vice dean Faculty of Allied Medical Science Pharos University in Alexandria Development and Regulation of Medical Products (MEDR-101)

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Prof. Moustafa M. Mohamed Vice dean Faculty of Allied Medical Science Pharos University in Alexandria Development and Regulation of Medical Products (MEDR-101)

This course aims to introduce an introduction to the process of medical product development with emphasis on the regulations that govern the design, fabrication, and maintenance of medical products.

Quality System 3 A Medical Device Quality System is designed to assure that products are Safe and Effective for their Intended Use and Consistently meet the specifications as defined by results of clinical and/or detailed technical design and validation

Design Process of Medical Equipment

Design Control Design & Development Planning Design input Design output Design review Design verification Design validation Design transfer Design changes Design history file

Three Key Elements 1.Design Input 2.Risk Analysis 3.Design Output

Design Input User Needs – what & why stated in user terms Marketing Requirements – measurable, engineering terms

US Food and Drug Administration (FDA)

Center for Drug Evaluation and Research (CDER) Center for Biological Evaluation and Research(CBER) Software Development & Research House (SDRH)

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