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Lourdes A. Medina
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Proceedings Papers

Design for FDA: A Predictive Model for the FDA’s Decision Time for Medical Devices

Lourdes A. Medina, Saylisse Dávila, Gül E. Okudan Kremer, Richard A. Wysk
Proc. ASME. IDETC-CIE2013, Volume 4: 18th Design for Manufacturing and the Life Cycle Conference; 2013 ASME/IEEE International Conference on Mechatronic and Embedded Systems and Applications, V004T05A021, August 4–7, 2013
Publisher: American Society of Mechanical Engineers
Paper No: DETC2013-13606
https://doi.org/10.1115/DETC2013-13606
View Paper titled, Design for FDA: A Predictive Model for the FDA’s Decision Time for Medical Devices
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Topics: Design, Food and Drug Administration, Frequency-domain analysis, Medical devices, Regulations
Proceedings Papers

Investigating the Relationship Between Product Design Complexity and FDA for Medical Device Development

Lourdes A. Medina, Marija Jankovic, Gül E. Okudan Kremer
Proc. ASME. IDETC-CIE2013, Volume 3A: 39th Design Automation Conference, V03AT03A015, August 4–7, 2013
Publisher: American Society of Mechanical Engineers
Paper No: DETC2013-13309
https://doi.org/10.1115/DETC2013-13309
View Paper titled, Investigating the Relationship Between Product Design Complexity and FDA for Medical Device Development
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Topics: Food and Drug Administration, Frequency-domain analysis, Medical devices, Product design, Design, Hip joint prostheses, Regulations, Safety
Proceedings Papers

An Analysis of Critical Factors in Medical Device Development to Design for FDA

Lourdes A. Medina, Gül E. Okudan Kremer, Richard A. Wysk
Proc. ASME. IDETC-CIE2012, Volume 5: 6th International Conference on Micro- and Nanosystems; 17th Design for Manufacturing and the Life Cycle Conference, 591-599, August 12–15, 2012
Publisher: American Society of Mechanical Engineers
Paper No: DETC2012-71054
https://doi.org/10.1115/DETC2012-71054
View Paper titled, An Analysis of Critical Factors in Medical Device Development to Design for FDA
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Topics: Design, Food and Drug Administration, Frequency-domain analysis, Medical devices
Proceedings Papers

An Analysis of Complexity Measures for Product Design and Development

Josue R. Crespo-Varela, Gül E. Okudan Kremer, Conrad S. Tucker, Lourdes A. Medina
Proc. ASME. IDETC-CIE2012, Volume 3: 38th Design Automation Conference, Parts A and B, 523-532, August 12–15, 2012
Publisher: American Society of Mechanical Engineers
Paper No: DETC2012-71309
https://doi.org/10.1115/DETC2012-71309
View Paper titled, An Analysis of Complexity Measures for Product Design and Development
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Topics: Product design, Medical devices, Robustness, Computer software, Design, Dimensions, Food and Drug Administration, Frequency-domain analysis, Health care, Manufacturing
Proceedings Papers

A Review of Design for X Methods for Medical Devices: The Introduction of a Design for FDA Approach

Lourdes A. Medina, Richard A. Wysk, Gu¨l E. Okudan Kremer
Proc. ASME. IDETC-CIE2011, Volume 9: 23rd International Conference on Design Theory and Methodology; 16th Design for Manufacturing and the Life Cycle Conference, 849-861, August 28–31, 2011
Publisher: American Society of Mechanical Engineers
Paper No: DETC2011-48348
https://doi.org/10.1115/DETC2011-48348
View Paper titled, A Review of Design for X Methods for Medical Devices: The Introduction of a Design for FDA Approach
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Topics: Design, Food and Drug Administration, Medical devices, Regulations
Journal Articles

An Ontology Model for the Medical Device Product Development Process and Environment

Lourdes A. Medina, Gül E. Okudan Kremer, Richard A. Wysk
Journal: Journal of Medical Devices
Publisher: ASME
Article Type: Design Of Medical Devices Conference Abstracts
J. Med. Devices. June 2011, 5(2): 027508.
https://doi.org/10.1115/1.3589290
Published Online: June 9, 2011
View Article titled, An Ontology Model for the Medical Device Product Development Process and Environment
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Topics: Medical devices, Ontologies, Product development, Patents, Artificial intelligence, Biomedical equipment