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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
Paper No: DETC2013-13606
DOI: https://doi.org/10.1115/DETC2013-13606
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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
Paper No: DETC2013-13309
DOI: https://doi.org/10.1115/DETC2013-13309
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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 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
Paper No: DETC2012-71309
DOI: https://doi.org/10.1115/DETC2012-71309
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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

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
Paper No: DETC2012-71054
DOI: https://doi.org/10.1115/DETC2012-71054
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Topics: Design, Food and Drug Administration, Frequency-domain analysis, Medical devices
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
Paper No: DETC2011-48348
DOI: https://doi.org/10.1115/DETC2011-48348
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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
Article Type: Design Of Medical Devices Conference Abstracts
J. Med. Devices. June 2011, 5(2): 027508.
DOI: https://doi.org/10.1115/1.3589290
Published Online: June 9, 2011
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Topics: Medical devices, Ontologies, Product development, Patents, Artificial intelligence, Biomedical equipment