ELT-61236 Biomedical Engineering: Research and Productization, 3 cr
Person responsible
Timo Allinniemi
Lessons
| Implementation | Period | Person responsible | Requirements |
| ELT-61236 2016-01 | 2 |
Timo Allinniemi |
Accepted exercise work and final exam. |
Learning Outcomes
Student can describe the life cycle of a biomedical device product research and development process. Student can recognize main standards and regulations concerning medical devices and can explain in general terms the laboratory and manufacturing practices such as GLP, GMP and GTP. Student is able to recognize the need for and methods of statistical testing of research material. Student can explain principles and tests for electrical and biological safety such as main sterilization methods and operation of clean rooms.
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:
Study material
| Type | Name | Author | ISBN | URL | Additional information | Examination material |
| Lecture slides | Yes |
Prerequisites
| Course | Mandatory/Advisable | Description |
| ELT-61216 Biomedical Engineering: Signals and Systems | Mandatory | 1 |
| ELT-61226 Biomedical Engineering: Biomaterials | Mandatory | 2 |
1 . ELT-61216 can be replaced with BME-1157 or LTT-1100.
2 . ELT-61226 can be replaced with BME-1167, BME-1120 or BIOM-1216.
Correspondence of content
| Course | Corresponds course | Description |
| ELT-61236 Biomedical Engineering: Research and Productization, 3 cr | BMT-61236 Biomedical Engineering: Research and Productization, 3 cr | |
| ELT-61236 Biomedical Engineering: Research and Productization, 3 cr | BME-1177 Biomedical Engineering: Research and Productization, 2 cr |