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CZECH TECHNICAL UNIVERSITY IN PRAGUE
STUDY PLANS
2024/2025

Quality, Reliability, Testing of Medical Devices

The course is not on the list Without time-table
Code Completion Credits Range Language
F7PMBKST ZK 3 2P+1C Czech
Garant předmětu:
Lecturer:
Tutor:
Supervisor:
Department of Biomedical Technology
Synopsis:

The aim of the course is to familiarize students with aspects that affect the quality, reliability and testing of medical products, i.e. quality management in healthcare. The course will discuss both the related standards used and the individual methods used in quality and reliability management of medical devices.

Requirements:

Credit requirements:

The student is required to complete the assigned practical tasks in the exercises. A maximum of 70 points is possible in the seminars. A minimum of 40 points is required for credit. In addition, the student is required to write a final credit test for a minimum of 50% points.

Exam evaluation:

A student awarded credit is evaluated on the basis of an oral examination. A grading scale is used for the final assessment, which is in accordance with the ECTS grading scale.

Syllabus of lectures:

Lecture outline:

- Basic concepts and approaches in quality system.

- Technical standardization systems. Basics of standards development.

- Quality management system - ISO 9000, 9001, 9004.

- Quality management system for medical devices - ISO 13 485

- Measurement management systems - ISO 10 012

- Quality management system audit - ISO 19 011

- Reliability of medical devices.

- Determination of reliability characteristics of medical devices.

- Statistical methods for quality assessment

- Standards in the field of medical device testing

Syllabus of tutorials:

The basis of the exercise:

- Application of ISO 9001

- Application of ISO 13 485

- Audit of quality management systems

- Application of ISO 10 012

- Determination and calculation of reliability characteristics

Study Objective:
Study materials:

MADAR, Jiří a kol. Řízení kvality ve zdravotnickém zařízení: vážně i nevážně k prosperitě nemocnic a spokojenosti pacientů. 1. vyd. Praha: Grada, 2004. 248 s. ISBN 80-247-0585-0.

MENTLÍK, Václav. Spolehlivostní aspekty elektrotechnologie. Praha: BEN - technická literatura, 2011. ISBN 978- 80-7300-412-5.

SEDLACEK, Milan. Kvalita a výkonnost průmyslových podniku. Brno: Masarykova univerzita, 2012. ISBN 9788021081741.

NENADÁL, Jaroslav. Moderní management jakosti: principy, postupy, metody. Praha: Management Press, 2008. ISBN 978-80-7261-186-7.

Note:
Further information:
No time-table has been prepared for this course
The course is a part of the following study plans:
Data valid to 2024-06-14
Aktualizace výše uvedených informací naleznete na adrese https://bilakniha.cvut.cz/en/predmet6242006.html