||BET404 - Medical Device Compliance
||For the correct edition of the textbook assigned to a specific class, go to: http://www.nutextdirect.com
|Course Description: Overview of medical device safety and applicable regulations including broad themes in medical device surveillance. Discussion of various regulatory agencies and how they oversee the various safety and regulatory aspects related to medical devices.
|Course Learning Outcomes:
- Demonstrate regulatory knowledge with regard to medical devices permitting and operation.
- Develop safety plans for the operation of medical devices used in clinical application.
- Acquire sufficient knowledge of fundamental physical principles related to the safety of medical devices.
- Evaluate specific unsafe practices in the operation of medical devices.
|Specified Program Learning Outcomes:
- Apply professional standards in decision-making.
- Communicate through written, verbal, and graphical media.
- Demonstrate a recognition of the need for, and an ability to engage in lifelong learning.
- Demonstrate awareness of professional, ethical and global issues in a diverse society.
Students with Disabilities:
Students seeking special accommodations due to a disability must submit an application with supporting documentation, as explained under this subject heading in the General Catalog. Instructors are required to provide such accommodations if they receive written notification from the University.
Writing Across the Curriculum:
Students are expected to demonstrate writing skills in describing, analyzing and evaluating ideas and experiences. Written reports and research papers must follow specific standards regarding citations of an author's work within the text and references at the end of the paper. Students are encouraged to use the services of the University's Writing Center when preparing materials.
The following website provides information on APA, MLA, and other writing and citation styles that may be required for term papers and the like: http://nu.libguides.com/citations
National University Library:
National University Library supports academic rigor and student academic success by providing access to scholarly books and journals both electronically and in hard copy. Print materials may be accessed at the Library in San Diego or through document delivery for online and regional students. Librarians are available to provide training, reference assistance, and mentoring at the San Diego Library and virtually for online or regional students. Please take advantage of Library resources:
Contact the Library:
- (858) 541-7900 (direct line)
- 1-866-NU ACCESS x7900 (toll free)
Use the Library Training Tools (on the Library Homepage) for additional help
- Recorded class presentations
- Tutorials & Guides (APA/MLA, Peer-Review, and more)
Plagiarism is the presentation of someone else's ideas or work as one's own. Students must give credit for any information that is not either the result of original research or common knowledge. If a student borrows ideas or information from another author, he/she must acknowledge the author in the body of the text and on the reference page. Students found plagiarizing are subject to the penalties outlined in the Policies and Procedures section of the University Catalog, which may include a failing grade for the work in question or for the entire course. The following is one of many websites that provide helpful information concerning plagiarism for both students and faculty: http://www.indiana.edu/~wts/pamphlets/plagiarism.shtml
Ethical behavior in the classroom is required of every student. The course will identify ethical policies and practices relevant to course topics.
Students are expected to be competent in using current technology appropriate for this discipline. Such technology may include word processing, spreadsheet, and presentation software. Use of the internet and e-mail may also be required.
Learning to work with and value diversity is essential in every class. Students are expected to exhibit an appreciation for multinational and gender diversity in the classroom.
As a diverse community of learners, students must strive to work together in a setting of civility, tolerance, and respect for each other and for the instructor. Rules of classroom behavior (which apply to online as well as onsite courses) include but are not limited to the following:
- Conflicting opinions among members of a class are to be respected and responded to in a professional manner.
- Side conversations or other distracting behaviors are not to be engaged in during lectures, class discussions or presentations
- There are to be no offensive comments, language, or gestures