Lecture 1 Product Development 101 - Intro - Weininger 30-Mar-2011

Lecture 1 Product Development 101 - Intro - Weininger 30-Mar-2011

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Center for Devices and Radiological Health Sandy Weininger, Ph.D. Plan for Quality BME 488/580 - Product Development 101 Drexel University, 30-Mar-2011
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Center for Devices and Radiological Health 30-Mar-2011 Drexel - Product Development 101 2 Who am I? Senior Biomedical Engineer Division of Electronics and Software Engineering Office of Science and Engineering Laboratories 10903 New Hampshire Ave Silver Spring, MD 20993 (301) 796 - 2582 sandy.weininger@fda.hhs.gov
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Center for Devices and Radiological Health 30-Mar-2011 Drexel - Product Development 101 3 Objectives Overview of FDA My responsibilities Regulations – primarily premarket Assuring safety thru risk management
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Center for Devices and Radiological Health 30-Mar-2011 Drexel - Product Development 101 4 FDA Organization FDA FDA CDRH CDRH CDER CDER CBER CBER CVM CVM CFSAN CFSAN ODE ODE OC OC OSEL OSEL OSB OSB ORA ORA OCER OCER OIVD Tobacco Tobacco
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Center for Devices and Radiological Health 30-Mar-2011 Drexel - Product Development 101 5 What I Do Forensic engineering Test method development Standards development
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Center for Devices and Radiological Health 30-Mar-2011 Drexel - Product Development 101 6 A Medical Device is: An instrument intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action or on not dependent upon being metabolized
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Center for Devices and Radiological Health 30-Mar-2011 Drexel - Product Development 101 7 Quality is? Effective design process Effective manufacturing process Effective postmarket processes ???
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Center for Devices and Radiological Health 30-Mar-2011 Drexel - Product Development 101 8 Product review to assure device safety and effectiveness Process review to assure quality of design Surveillance to monitor device quality
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Development Model Picture courtesy of Al Taylor, FDA 9 Center for Devices and Radiological Health
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review FDA Review of Development Planning Milestone Requirements Definition ID hazards, env. Detailed Design Materials, performance characteristics Verification testing to show Validation Clinical protocols, methodologies, consent forms FDA Review of Design Control Management control, Resource planning Procedures address design inputs Procedures address design outputs Plans establish conformance of Design Out to In Validation planned and reviewed. 10
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Lecture 1 Product Development 101 - Intro - Weininger 30-Mar-2011

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