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

Course requirements:

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.