|
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.
|