BMT-62236 Medical Device Research and Productization, 5 cr
Person responsible
Timo Allinniemi
Lessons
| Implementation | Period | Person responsible | Requirements |
| BMT-62236 2018-01 | 2 |
Timo Allinniemi |
Accepted exercise work and final exam. |
Learning Outcomes
Student can describe the life cycle and main steps of a biomedical device product research and development process. Student can understand the main principles and challenges of medical device development. Student can recognize main standards and regulations concerning medical devices and can explain the main parts of the quality systems for the medical devices. Student can explain main principles and most typical tests for electrical and biological safety as well as mechanical and biomechanical testing.
Content
| Content | Core content | Complementary knowledge | Specialist knowledge |
| 1. | Most common phases of R&D project. From research to the product launch. | Understanding the connections between different phases of the project, and to have overall knowledge about the whole process. | |
| 2. | Quality Systems for medical device development. Why it's needed? And how we can use it to improve the product safety? | Deeper understanding of QS (including SOP, CAPA, Auditing, DMR, traceability, risk assessment) | |
| 3. | Medical Devices. Definitions, packaging, sterilization, registrations and regulatory. | Understanding the main equalities and differences of regulatory demands between the different countries. | |
| 4. | Testing (mechanical, biomechanical, clinical, and statistical), standards and safety (electrical, biological). | To understand the main methods and why/where we need these results? |
Instructions for students on how to achieve the learning outcomes
Grades 1-2: Learning outcomes have been achieved. Satisfactory command in core content of the course. Grades 3-4: Some learning outcomes have been exceeded qualitatively or quantitatively. Good command in core content and complementary knowledge of the course. Good or very good marks from all parts of the course. Grade 5: Most of the learning outcomes have been exceeded. Deep command in the whole content of the course. Almost maximum performance in all parts of the course.
Assessment scale:
Numerical evaluation scale (0-5)
Partial passing:
Correspondence of content
| Course | Corresponds course | Description |
| BMT-62236 Medical Device Research and Productization, 5 cr | BMT-62237 Introduction to Quality and Regulation for Medical Product Development, 5 cr | |
| BMT-62236 Medical Device Research and Productization, 5 cr | BMT-61236 Biomedical Engineering: Research and Productization, 3 cr |