Regulatory requirements for design and manufacture of medical devices
After completing this course, the student:
- is able to describe the regulatory pathway of a medical device from description of the intended purpose to placing into market and putting into service
- is able to recognise the general safety and performance requirements for a medical device including the principles of risk management and clinical evaluation
- can explain the main elements of a quality system covering design and manufacture and choose a conformity assessment procedure based on classification rules
- is able to understand the main principles and challenges of vigilance system and post-market surveillance
You can either attend the lectures in Tampere University’s campus or watch them online. If student misses a lecture, they will be given an extra assignment. Course exercises are the same for all students, regardless of how they complete the course.
More information in Tampere University’s study guide.
Contact person for applications