LLTS009 Health Science and Technology (3 op)
Kuvaus
Content
Using current information to evaluate future trends in wellness and health technology
Legislation and regulation of technologies and services in sports, health and medicine
European medical device database (EUDAMED)
Scientific basis; ethics and risk management
Scientific basis; validity and reliability
Conformity assessment procedures
Completing methods
Lectures and seminars 20 hours
Independent group work and its presentation (may be done individually, in pairs or in larger groups based on number of students at course)
Literature and book reading
Active participation in the lectures and group work and writing assignments, examination based on set literature or written report of group work and its oral presentation.
Assessment details
Assessment details
Participation, group work or final exam/written report
Attendance to course lectures/seminars 90% in order to pass the course. Note! Oral seminar presentations cannot be substituted by other work.
Osaamistavoitteet
On successful completion of this course, student is able to
find the basic information on health/wellness technology market and trends
differentiate medical device from other types of health technologies
describe how medical, health and wellness technologies or services are regulated
build link between scientific knowledge and research and development (R&D) products
evaluate health and wellness technologies or services -associated safety, risk management and ethics -related issues
recognize the general safety and performance requirements for medical device (MD) and in-vitro diagnostic (IVD) products
Lisätietoja
Spring
Oppimateriaalit
Dhillon, B.S. 2000. Medical device reliability and associated areas. Boca Raton: CRC Press. (240 p.) Chapters included in the exam will be told at the lectures.
Onel, S. & Becker, K.M. (eds.) 2014. Medical devices law and regulation answer book 2014. New York, NY: Practising Law Institute. (1000 p.)
Study materials:
Bankert, E.A. & Amdur, R.J. 2005. Institutional review board: management and function. 2nd edition. Boston, MA: Jones & Bartlett. (530 p.)
Simmers, L., Simmers-Nartker, K., Simmers-Kobelak, S. 2008. Introduction to health science technology. 2nd edition. Clifton Park, NY: Delmar Cengage Learning. (656 s.)
Wassertheil-Smoller, S. 2004. Biostatistics and epidemiology: a primer for health and biomedical professionals. 3. painos. New York, NY:Springer. (243 s.)