Introduction to quality and regulation for medical product development
Max amount of FITech students: 20
The course provides basic information on regulatory and quality requirements for medical products throughout the product’s life cycle. The course introduces the key concepts and definitions in the field and the stages of product development. Versatile product testing, product safety verification and related standards and requirements will be introduced.
- Most common phases of R&D project from research to the product launch.
- Quality systems for medical device development. Why it’s needed and how we can use it to improve the product safety?
- Medical devices. Definitions, packaging, sterilization, registrations and regulatory.
- Testing (mechanical, biomechanical, clinical, and statistical), standards and safety (electrical, biological).
After completing the course, you:
- can explain the definitions introduced in the course and the main steps of a biomedical device product research and development process
- 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
- can explain the most typical tests for electrical and biological safety as well as mechanical and biomechanical testing
More information in Tampere University’s study guide.