Quality, Reliability&Testing and Clinical Evaluation of Medical Devices

Lecturer:

Tutor:

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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.

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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:

Further information:

No time-table has been prepared for this course

The course is a part of the following study plans:

• Navazující magisterský studijní obor Systémová integrace procesů ve zdravotnictví - prezenční (compulsory course)