Quality, Reliability, Testing of Medical Devices

Garant předmětu:

Peter Kneppo

Lecturer:

Jiří Hozman, Vojtěch Kamenský, Peter Kneppo

Tutor:

Eliška Friebová, Vojtěch Kamenský

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:

Time-table for winter semester 2023/2024:

Time-table is not available yet

Time-table for summer semester 2023/2024:

	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	roomKL:B-420 Kneppo P. Kamenský V. 14:00–15:50 (lecture parallel1) Kladno FBMI UčebnaroomKL:B-433 Kamenský V. 16:00–17:50 (lecture parallel1 parallel nr.1) Kladno FBMI Lab. KI a MZT roomKL:B-420 Hozman J. 14:00–15:50 (lecture parallel2) Kladno FBMI Učebna
Tue
Wed
Thu
Fri

The course is a part of the following study plans:

• Biomedical Engineering (compulsory course)