BMT-62237 Introduction to Quality and Regulation for Medical Product Development, 5 cr
Person responsible
Timo Allinniemi, Minna Kellomäki
Lessons
| Implementation | Period | Person responsible | Requirements |
| BMT-62237 2019-01 | 4 |
Timo Allinniemi Minna Kellomäki |
Accepted exercise work (three mandatory exercises) and final exam. |
Learning Outcomes
Student can explain the definitions of the course and the main steps of a biomedical device product research and development process. Student can explain the main standards and regulations concerning medical devices in EU and USA and the main parts of the most common quality systems for the medical devices. Student can explain the 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: Knows the basic definitions of the course and can describe the main steps of a biomedical device product research and development process. Student can recognize main standards and regulations concerning medical devices and can define the main parts of the quality systems for the medical devices. Student can list the most typical tests for electrical and biological safety as well as mechanical and biomechanical testing. Satisfactory command in core content of the course. Grades 3-4: Student can explain the definitions of the course and the main steps of a biomedical device product research and development process. Student can explain the main standards and regulations concerning medical devices in EU and USA and the main parts of the most common quality systems for the medical devices. Student can explain the most typical tests for electrical and biological safety as well as mechanical and biomechanical testing. Good command in core content and complementary knowledge of the course. Good or very good marks from all parts of the course. Grade 5: Student can combine and utilize given topics of the course together creating deeper understanding about the context by using real life medical examples as a reference. All the learning outcomes have been exceeded. Deep command in the whole content of the course, including the exercises. 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-62237 Introduction to Quality and Regulation for Medical Product Development, 5 cr | BMT-62236 Medical Device Research and Productization, 5 cr |