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BIOE 8481: Cellular-Biomaterials Int Lab
0.00 Credits
Clemson University
Non-credit laboratory to accompany BIOE 8480. Coreq: BIOE 8480.
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BIOE 8481 - Cellular-Biomaterials Int Lab
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BIOE 8490: Tissue Engineering
3.00 Credits
Clemson University
Principles and practices of bioartificial organ and tissue development; cellular/material interaction and translation of information from two-dimensional surfaces to three-dimensional scaffolds; selection and processing of biomaterials to form tissue scaffolds; analysis of tissue engineered devices, standards and regulation. Preq: BIOE 8010 and BIOE 8460.
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BIOE 8500: Selected Topics
1.00 Credits
Clemson University
Advanced topics in bioengineering intended to develop in-depth areas of particular student interest. Credit may be earned for more than one semester.
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BIOE 8500 - Selected Topics
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BIOE 8510: Mentoring Undergrad Res Teams
1.00 Credits
Clemson University
Provides students with training and practical experience for managing and leading teams engaged in scientific research and medical device design/development. Students receive training from a faculty instructor while mentoring teams of undergraduate researchers. May be repeated for a maximum of six credits. Preq: Consent of instructor.
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BIOE 8600: Biomed Engr Design Innovation
3.00 Credits
Clemson University
In-depth review of regulatory, engineering, manufacturing and sterilization considerations required for the design and commercial development of medical devices.
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BIOE 8600 - Biomed Engr Design Innovation
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BIOE 8610: Biomed Eng Product Translation
3.00 Credits
Clemson University
Graduate student teams work to iteratively design and prototype a medical device based on an identified clinical need and ultimately test their designs according to U.S. Food and Drug Administration (FDA) guidance documents and consensus standards prior to authoring a pre-market submission to the FDA for their device. Preq: BIOE 8600. Coreq: BIOE 8611.
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BIOE 8610 - Biomed Eng Product Translation
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BIOE 8611: Biomed Engr Prod Trans Lab
0.00 Credits
Clemson University
Non-credit laboratory to accompany BIOE 8610. Coreq: BIOE 8610.
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BIOE 8611 - Biomed Engr Prod Trans Lab
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BIOE 8620: Pre-Clin & Reg Aff for Med Dev
3.00 Credits
Clemson University
Addresses the common pre-clinical requirements and regulatory processes required for medical device commercialization. Lectures focus on the regulatory pathways and submission processes, pre-clinical study design, protocol development and testing, and quality assurance and risk management as it applies to medical devices.
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BIOE 8630: Reg & Clinical Aff for Med Dev
3.00 Credits
Clemson University
Addresses the regulatory pathway and clinical research process required for medical device commercialization. Lectures focus on the roles and responsibilities of regulatory and clinical affairs departments, clinical trial design, protocol writing, data collection and reporting, quality assurance in clinical trials, and risk management.
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BIOE 8630 - Reg & Clinical Aff for Med Dev
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BIOE 8660: Reg Reqts of Quality-MedTech
3.00 Credits
Clemson University
This course provides students with an understanding of the United States and international regulations for the medical device, pharmaceutical, and life science industries. Students are introduced to fundamental concepts in the regulations related to clinical trial development, management, ethics, data integrity, data security, privacy, change control, and validation.
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