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CZECH TECHNICAL UNIVERSITY IN PRAGUE
STUDY PLANS
2024/2025

Certification of Medical Technology

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Code Completion Credits Range Language
F7PMBCZT Z,ZK 3 1P+1C Czech
Garant předmětu:
Peter Kneppo
Lecturer:
Ondřej Gajdoš, Vojtěch Kamenský, Peter Kneppo
Tutor:
Ondřej Gajdoš, Vojtěch Kamenský
Supervisor:
Department of Biomedical Technology
Synopsis:

The course deals with the issue of placing medical devices on the market. The syllabus of the course is designed to cover the main steps in the process of CE marking and marketing.

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:

EU medical device certification system.

Preclinical testing of medical devices

Clinical evaluation of medical devices

Conformity assessment, cooperation with notified bodies

National (RZPRO) and European medical device databases (EUDAMED), vigilance system.

Specifics of medical devices with measuring function and sources of ionising radiation

Syllabus of tutorials:

Work with legislative documents (EU Regulation 2017/745, MEDDEV)

Biocompatibility, electrical safety testing

Clinical evaluation 1 - clinical trials

Clinical evaluation 2 - equivalence, literature search

Technical documentation for conformity assessment

Adverse event reporting and management systems (vigilance system)

Study Objective:
Study materials:

Fundamentals of EU Regulatory Affairs. 8th. Regulatory Affairs Professionals Society (RAPS), 2017. ISBN 978- 1947493032.

Note:
Time-table for winter semester 2024/2025:
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
roomKL:B-433
Kamenský V.
Gajdoš O.

16:00–17:50
EVEN WEEK

(lecture parallel1
parallel nr.1)

Kladno FBMI
Lab. KI a MZT
roomKL:B-433
Kneppo P.
Kamenský V.

16:00–17:50
ODD WEEK

(lecture parallel1)
Kladno FBMI
Lab. KI a MZT
roomKL:B-433
Gajdoš O.
16:00–17:50
ODD WEEK

(lecture parallel2)
Kladno FBMI
Lab. KI a MZT
Wed
Thu
Fri
Time-table for summer semester 2024/2025:
Time-table is not available yet
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/predmet6241206.html