Code: | MI074163 | Acronym: | DSPMED |
Keywords | |
---|---|
Classification | Keyword |
OFICIAL | Health Sciences |
Active? | Yes |
Responsible unit: | Pharmaceutical Technology Laboratory |
Course/CS Responsible: | MSc in Pharmaceutical Sciences |
Acronym | No. of Students | Study Plan | Curricular Years | Credits UCN | Credits ECTS | Contact hours | Total Time |
---|---|---|---|---|---|---|---|
MICF | 39 | Official Curriculum | 4 | - | 4 | 52 | 108 |
Provide students with a thorough knowledge on the technical, scientific and regulatory aspects concerning Medical Devices and “in vitro” Diagnostic Medical Devices, in order to give them the necessary skills for a good professional performance in the different fields of these matters, namely in manufacturing, quality control, marketing authorization, wholesale distribution, selection, acquisition, storage, preserving, counseling and dispensing.
Learning outcomes:
At the end of this course, students should master the technical, scientific and regulatory aspects related to Medical Devices and “in vitro” Diagnostic Medical Devices.
Skills:
Appropriate skills for a good professional performance in the different fields of these matters, namely in manufacturing, quality control, marketing authorization, wholesale distribution, selection, acquisition, storage, preserving, counseling and dispensing.
The Program of this subject has been organized under the assumption that students have knowledge of Anatomy, Histology, Physiology, Biochemistry, Microbiology, Pharmacology, Immunology and Pharmaceutical Technology.
1) Introduction and General Concepts
1.1) Characterization of concepts
1.1.1) Medical Device
1.1.1.1) Active Medical Device
1.1.1.2) Nonactive Medical Device
1.1.1.3) Custom-made Medical Device
1.1.1.4) Medical Device intended for clinical investigation
1.1.1.5) Medical Device systems and sets for medical procedures
1.1.2) “in vitro” Diagnostic Medical Devices
1.2) Classification of Medical Devices in risk classes
1.2.1) Fundamentals of classification and application criteria
1.2.2) Practical implications of the classification of the Medical Devices
1.3) Classification of “in vitro” Diagnostic Medical Devices in risk classes
1.3.1) Fundamentals of classification and application criteria
1.3.2) Practical implications of the classification of “in vitro” Diagnostic Medical Devices
2) Regulatory issues
2.1) Placing of Medical Devices and “in vitro” Diagnostic Medical Devices on the market
2.2) Conformity Assessment of Medical Devices and “in vitro” Diagnostic Medical Devices
2.3) Competent Authority and its functions
2.4) Notified Body and its functions
2.5) CE marking
2.6) EC declaration of conformity and EC certificate of conformity
2.7) Labelling and leaflet / instructions manual of Medical Device and “in vitro” Diagnostic Medical Devices. Symbology harmonized.
2.8) Vigilance of Medical Devices
2.8.1) Objectives
2.8.2) Definitions and concepts
2.8.3) Organization of the Medical Devices National Vigilance System
2.8.4) Notification
2.9) Collection and disposal of Medical Devices
3) Study of more common devices
3.1) Dressing material
3.2) Devices for individuals ostomates
3.3) Devices for urinary incontinence
3.4) Devices for Orthopedics
3.5) Sutures
3.6) Devices for drainage, dilatation and irrigation
3.7) Devices for measuring blood pressure
3.8) “in vitro” Diagnostic Medical Devices for self-testing (glycemia, glycosuria, ketonuria, cholesterol, plasma triglycerides, pregnancy)
3.9) Other self-tests
Theoretical classes: 2 x 50 minutes / week.
Practical/Laboratorial classes: 2 hours / week, for planning and conducting laboratory tests and exercises
In addition to the established schedules for lectures and laboratory classes, teachers are available to meet students at any time previously agreed.
designation | Weight (%) |
---|---|
Exame | 80,00 |
Trabalho laboratorial | 20,00 |
Total: | 100,00 |
designation | Time (hours) |
---|---|
Estudo autónomo | 45,00 |
Frequência das aulas | 45,00 |
Trabalho de campo | 10,00 |
Total: | 100,00 |
EVALUATION COMPONENTS:
- DISTRIBUTED COMPONENT is valued on the basis of works presented by students in the practical/laboratory classes along the term (20%).
- FINAL EXAMINATION consists on a written exam that focuses on all subjects actually taught in lectures and practical/laboratorial classes along the term (80%).
Students with a score lower than 9.5 in the final examination are considered failed.
Students with a score equal to or higher than 9.5 in the final examination are admitted to the final score calculation.
FINAL SCORE CALCULATION (0-20):
Final examination score x 0.8 + Distributed component score x 0.2
Students with a final score equal to or higher than 9.5 are considered approved.
Students with a final score lower than 9.5 are considered failed.
ORAL EXAMINATION:
Students who have obtained final score equal to or higher than 9.5 may voluntarily apply for an oral examination in order to improve their score on the Curricular Unit.
Students should deliver the application in SGAE 48 hours after publication of the ratings.
Oral examination covers all materials actually taught in lectures and practical/laboratorial classes along the term.
When an oral examination occurs, the final score is only dependent on the performance of the students on this examination.