Study Guide

Description

Introduction Medical Technology learning path focuses on medical devices, medical device context of use, and regulation that controls the devices itself but also business related medical devices. Medical devices are defined in EU regulation 2017/745. Medical devices are intended, for example, for diagnosis, prevention, monitoring, prediction, prognosis, treatment of disease. Device can be e.g. medical imaging device, patient monitor, software, system or Artificial Intelligence. EU regulation sets strict requirements for medical devices used in European markets. Medical devices are used in different clinical environments, by various users and under defined care guidelines and processes. Devices must suit for their intended purpose and achieve the performance intended by manufacturer, and the use of devices must be safe. Content The Medical Technology learning path extent is 60 ECTS and it is divided into courses (30 ECTS) and Master’s thesis (30 ECTS). The learning path includes following courses. Medical Devices and Environments of Use course focuses on medical devices including software, clinical environments where medical devices are used, and requirements that the context of use gives to medical devices. Regulations and Standards course gives the latest information related to medical device regulation and essential standards used to fulfill the requirements originated from the regulation. Safety related Usability course offers tools for improving usability and taking safety of use into account when developing medical devices. Medical Device Life Cycle course will provide the understanding of medical device life cycle that is highly dependent on strict requirements for safety, performance and intended purpose of use. Research Methods and Skills course provide the required knowledge to prepare and facilitate a high quality Master’s thesis. Student chooses Elective course from Metropolia UAS Master’s Degree Programs or elsewhere, elective course can also be Master level online course. Competence Essential competence achieved in Medical Technology learning path is: 1) Understanding the requirements set by legislation for manufacturer and other parties involved, and medical device context of clinical use, 2) Managing methods and tools used for responding to the requirements of the legislation, defining requirements and developing safe and usable medical devices, and 3) Applying learned knowledge and skills in medical devices life cycle, in practice. Implementation The Medical Technology learning path is implemented in the following way. The first study year (autumn 2021 - spring 2022) focuses on the above-mentioned courses, and planning and conducting Master’s thesis. There will be face-to-face teaching and workshops on two consecutive days once a month, and online teaching and individual guidance related to the assignments on two consecutive days once a month. Second study year (autumn 2022) focuses on finalizing Master’s thesis and there will be online workshops once a month.