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Materials and Medical Devices

Code 12868
Year 1
Semester S1
ECTS Credits 6
Workload T(30H)/TP(30H)
Scientific area Bioengenharia
Entry requirements Not applicable.
Mode of delivery Face-to-face
Work placements Not applicable
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
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
Main Bibliography - The Medical Device R&D Handbook (e-Livro Google), Theodore R. Kucklick, CRC Press, 2005
- Design, Execution, and Management of Medical Device Clinical Trials, Abdel-aleem, Salah M. , John Wiley & Sons Inc, 2009
- Design for Six-sigma for Medical Devices, El-Haik, Basem, John Wiley & Sons Inc, 2008
- Medical Devices, Altensetter, Christa; Transaction Pub, 2007
- Medical Instruments and Devices - Principles and Practices, (Ed.) S. Schreiner, J.D. Bronzino, D.R. Peterson, CRC Press, Taylor &
Francis Group, 2016.
- WHO compendium of innovative health technologies for low-resource settings (2011-2014), World Health Organization (WHO), 2015.
- Design of medical electronic devices, R. Perez, Academic Press, Elsevier, 2002.
- Handbook of Materials for Medical Devices, (Ed.) J.R. Davis, ASM International, 2003.
- Biomaterials and Medical Devices - A Perspective from an Emerging Country, (Ed.) F. Mahyudin et al., Springer International, 2016.
- EC regulations about Medical Devices.
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 (30%)
EV2 - Evaluation test 2 (25%)
PRO - Research project (45%)

Final mark = EV1+EV2+PRO
Language Portuguese. Tutorial support is available in English.
Last updated on: 2020-01-17

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