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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)

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Presentation on theme: "Prof. Moustafa M. Mohamed Vice dean Faculty of Allied Medical Science Pharos University in Alexandria Development and Regulation of Medical Products (MEDR-101)"— Presentation transcript:

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

2 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.

3 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

4 Design Process of Medical Equipment

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

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

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

8 US Food and Drug Administration (FDA)

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

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