| Code |
12868
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| Year |
1
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| Semester |
S1
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| ECTS Credits |
6
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| Workload |
T(30H)/TP(30H)
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| Scientific area |
Bioengenharia
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|
Entry requirements |
Not applicable.
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Mode of delivery |
Face-to-face
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Work placements |
Not applicable
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|
Learning outcomes |
- Understand the concept of Medical Device
- Address the recognition of clinical needs for use of medical devices, instruments and diagnostic
systems
- To apply the Portuguese and European regulations on medical devices
- Understanding the life cycle of medical devices - from idea to post-marketing surveillance
- Understand the design methodology of a clinical trial
- Understand the principles of the relationship between materials, their properties and the human body: notions of biocompatibility, toxicity and durability.
- Understand the risk to health and basic safety procedures the patient
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Syllabus |
Module 1:
- Medical device definition, uses and aims.
- Clinical perspectives: Clinical Problems Requiring for Solution
- Characterization of different types of medical devices and diagnostic systems.
- Regulation of medical devices: Certification, Security, biocompatibility, bioanalytical,
wireless/telemedicine, etc.
- Life cycle of medical devices.
- Clinical assays requirements and methodology
Module 2:
- Topics on the interaction of materials and human body: Patient security perspectives.
- Characteristics and properties of polymeric, metal, ceramic and titanium alloys materials used in medical devices
- Fatigue life, corrosion and durability of medical devices
- Advanced materials and emerging technologies (lighter weight, silent, more power efficient and less intrusive implantable devices)
- Surface engineering of medical devices (novel and established surface treatments and
technologies)
- Research on medical devices
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Main Bibliography |
Kucklick, T. R. (2012). The medical device R&D handbook (2nd ed.). CRC Press.
Schreiner, S., Bronzino, J. D., & Peterson, D. R. (Eds.). (2015). Medical instruments and devices: Principles and practices. CRC Press.
WHO compendium of innovative health technologies for low-resource settings, World Health Organization (WHO), 2024.
Perez, R. (2002). Design of medical electronic devices. Academic Press
Narayan, R. J. (Ed.). (2012). ASM handbook, Volume 23: Materials for medical devices. ASM International.
Mahyudin, F., & Hermawan, H. (Eds.). (2016). Biomaterials and medical devices: A perspective from an emerging country. Springer
- EC regulations about Medical Devices:
European Parliament and Council. (2017). Regulation (EU) 2017/745 on medical devices (consolidated version 10 January 2025). EUR-Lex.
European Parliament and Council. (2017). Regulation (EU) 2017/746 on in vitro diagnostic medical devices (consolidated version 10 January 2025). EUR-Lex.
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Teaching Methodologies and Assessment Criteria |
The teaching/learning activities for the contents seizure regarding skills to be acquired are distributed along: theoretical and theoretical-practical.
Teaching methodologies:
- Theoretical exposure of course contents;
- Theoretical-practical lectures for problem solving in the various topics covered in the syllabus.
Assessment methods and criteria:
EV1 - Evaluation test 1 (20%)
PRO - Research project (80%)
Minimum classification in the teaching/learning assessment:
PR1 - Evaluation test 1: 6 marks
PRO - Research project: 9.5 marks
CF - Final classification:
CF=PR1+PRO
Classification by exam is based on:
EX - Exam (20%)
PRO - Maintenance of the classification obtained throughout the semester in the development project (80%)
CF - Final classification:
CF=EX+PRO
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Language |
Portuguese. Tutorial support is available in English.
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