Clinical Trials and Assessment of Medical Devices

In order to register for the course F7AMBKHZP, the student must have successfully completed the course F7AMBELEG in a previous semester.

Garant předmětu:

Lecturer:

Tutor:

Supervisor:

Department of Biomedical Technology

Synopsis:

The course focuses on the process of clinical evaluation of medical devices when placing a medical device on the market. The course covers theoretical and practical issues of clinical trials, clinical evaluation using literature searches, and preclinical trials.

Requirements:

Credit requirements:

The student is required to complete the assigned practical tasks in the exercises. A maximum of 70 points is possible on the exercises. 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:

1. Legislation related to the placing on the market of a medical device

2.Preclinical testing of medical devices

3. Clinical trial 1 - documentation of the clinical trial

4. Clinical Trial 2 - Practical conduct of a clinical trial

5.Clinical evaluation and equivalence of medical devices

6.Data processing methods in clinical trials

7.PMS (Post Market Surveillance) and PMCF (Post Market Clinical Follow Up) monitoring for medical devices

Syllabus of tutorials:

1. Biocompatibility for medical devices

2.Clinical trial design

3.Development of supporting documentation for clinical trials

4. Ethical issues in clinical trials - informed consent

5. Equivalence of medical devices in clinical trials

6.Processing of clinical trial outputs

7. PMS and PMCF plan development and evaluation

Study Objective:

Study materials:

Mandatory:

-DEMARCO, Carl T. Medical device design and regulation. Milwaukee: ASQ Quality Press, c2011. ISBN 9780873898164

-BECKER, Karen M. a John J. WHYTE. Clinical evaluation of medical devices. 2nd ed. Totowa, N.J.: Humana Press, c2006. ISBN 978-1-58829-422-7.

-POMMELIN, Petri. The Survival Guide to Eu Medical Device Regulations. Berlin: Books on Demand, 2017. ISBN 978-9515681201.

Recommended::

-Guidance (MEDDEV). European commission [online]. [ref. 2019-05-02]. Available from: http://ec.europa.eu/growth/sectors/medical-devices/current-directives/guidance_en#meddevs

-European Union health law: treaties and legislation. Editor André den EXTER, editor Tamara K. HERVEY. Apeldoorn: Maklu, 2012. ISBN 978-90-466-0544-8.

Note:

Further information:

No time-table has been prepared for this course

The course is a part of the following study plans:

• Biomedical and Clinical Engineering (compulsory elective course)