| Code |
12029
|
| Year |
1
|
| Semester |
S1
|
| ECTS Credits |
6
|
| Workload |
T(30H)/TP(30H)
|
| Scientific area |
Química Medicinal
|
|
Entry requirements |
Non aplicable
|
|
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
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Language |
Portuguese. Tutorial support is available in English.
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