Quality, Relialibity & Medical Technology Assessment
| Code | Completion | Credits | Range | Language |
|---|---|---|---|---|
| 17MSJSH | Z,ZK | 4 | 2+2 | Czech |
- Lecturer:
- Peter Kneppo (gar.)
- Tutor:
- Ilya Ivlev, Lukáš Roubík
- Supervisor:
- Department of Biomedical Technology
- Synopsis:
-
Review of aspects affecting quality, reliability and testing of health care products and preparation and duration of clinical testing. Quality management in healh care facility. Reliability of elements, modules, the whole technical devices and software solutions as well. Recommendations and experiences from European Union. Related law standards. Compliance assessment based on government decree and relationships with quality management.
- Requirements:
- Syllabus of lectures:
- Syllabus of tutorials:
- Study Objective:
-
The main aim of this subject is to provide an integrative explanation of relationships among quality systems, reliability, testing and clinical testing processes with practical apects. Subject prepares students for application of thier knowledge in health care practice.
- Study materials:
-
[1]Karen M. Becker: Clinical Evaluation of Medical Devices: Principles and Case Studies. Humana Press; 1 edition (Oct 7 1997). 288 s.
[2]Karen M. Becker, John J. Whyte: Clinical Evaluation of Medical Devices: Principles and Case Studies. Humana Press; 2 edition (2006).
[3]Richard C. Fries: Handbook of Medical Device Design. Marcel Dekker, New York, 2001. 774 s.
[4]Paul H. King, Richard C. Fries: Design of Biomedical Devices and Systems. Marcel Dekker, New York, 2003. 585 s.
[5]Richard C. Fries: Reliable Design of Medical Devices. Marcel Dekker, New York, 1997. 703 s.
- Note:
- Time-table for winter semester 2011/2012:
- Time-table is not available yet
- Time-table for summer semester 2011/2012:
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06:00–08:0008:00–10:0010:00–12:0012:00–14:0014:00–16:0016:00–18:0018:00–20:0020:00–22:0022:00–24:00
Mon Tue Fri Thu Fri - The course is a part of the following study plans: