Week |
Subject |
Related Preparation |
1) |
HF (preliminary) Analysis Requirements in the early stages of device development, FDA User-Device Model
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2) |
Formative Evaluation and Design Modification
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3) |
Planning and executing HF/Usability validation studies
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4) |
HF/Usability Report
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5) |
Overview of Human Factors Medical Device Standards
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6) |
Planning and Conducting HF for Medical Devices
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7) |
Midterm Exam |
|
8) |
FDA and ISO 13485 Design Control Requirements, Design and Development Planning Continues
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9) |
Design Input, Risk Management and Design Output
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10) |
Design Review, Design Verification and Validation
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11) |
Design Transfer
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12) |
Software Validation
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14) |
Pilot Production and Volume Production
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14) |
Design Changes and Design History File
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Course Notes / Textbooks: |
Power Point Presentations, Design for Biomedical Engineers J. Webster R. Pallas-Areny, e-book, 2015; Design and Development of Medical Electronic Instrumentation, D. Pruychi and M. Norris, John-Wiley and Sons, 2005.
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References: |
Standards ANSI/AAMI HE 75 and EN 62366-1; Design Control Requirements and Industry Practice, AAMI corse e-notebook, 2016;Human Factors for Medical Devices, AAMI course e-notebook, 2013; Overview of International Medical device Human Factors Standards,, K. İsraelski, Abbott; An Introduction to Human Factors in MEdical DEvices, Do It By Design, D. Sawyer, CDRH, FDA.
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Program Outcomes |
Level of Contribution |
1) |
Adequate knowledge of subjects specific to mathematics (analysis, linear, algebra, differential equations, statistics), science (physics, chemistry, biology) and related engineering discipline, and the ability to use theoretical and applied knowledge in these fields in complex engineering problems. |
|
2) |
Identify, formulate, and solve complex Biomedical Engineering problems; select and apply proper modeling and analysis methods for this purpose |
4 |
3) |
Design complex Biomedical systems, processes, devices or products under realistic constraints and conditions, in such a way as to meet the desired result; apply modern design methods for this purpose. |
3 |
4) |
Devise, select, and use modern techniques and tools needed for solving complex problems in Biomedical Engineering practice; employ information technologies effectively. |
4 |
5) |
Design and conduct numerical or physical experiments, collect data, analyze and interpret results for investigating the complex problems specific to Biomedical Engineering. |
4 |
6) |
Cooperate efficiently in intra-disciplinary and multi-disciplinary teams; and show self-reliance when working on Biomedical Engineering-related problems. |
5 |
7) |
Ability to communicate effectively in Turkish, oral and written, to have gained the level of English language knowledge (European Language Portfolio B1 general level) to follow the innovations in the field of Biomedical Engineering; gain the ability to write and understand written reports effectively, to prepare design and production reports, to make effective presentations, to give and receive clear and understandable instructions. |
3 |
8) |
Recognize the need for life-long learning; show ability to access information, to follow developments in science and technology, and to continuously educate oneself. |
5 |
9) |
Having knowledge for the importance of acting in accordance with the ethical principles of biomedical engineering and the awareness of professional responsibility and ethical responsibility and the standards used in biomedical engineering applications |
4 |
10) |
Learn about business life practices such as project management, risk management, and change management; develop an awareness of entrepreneurship, innovation, and sustainable development. |
4 |
11) |
Acquire knowledge about the effects of practices of Biomedical Engineering on health, environment, security in universal and social scope, and the contemporary problems of Biomedical Engineering; is aware of the legal consequences of Mechatronics engineering solutions. |
4 |