Clinical Trials and Assessment of Medical Devices
Code | Completion | Credits | Range | Language |
---|---|---|---|---|
F7AMBKHZP | Z,ZK | 3 | 1P+1C | English |
- Relations:
- In order to register for the course F7AMBKHZP, the student must have successfully completed the course F7AMBELEG in a previous semester.
- Course guarantor:
- Lecturer:
- Tutor:
- Supervisor:
- Department of Biomedical Technology
- Synopsis:
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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:
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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:
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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:
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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:
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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:
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- Biomedical and Clinical Engineering (compulsory elective course)