Regulatory requirements for design and manufacture of medical devices

Max amount of FITech students: 20

The course provides in-depth information to the requirements and regulations for medical devices. The main emphasis is on the EU Medical Devices Regulation (MDR). Technical documentation, quality management system, risk management, clinical evaluation, post market surveillance, conformity assessment procedures, vigilance system and the role of conformity assessment bodies will become familiar with this course.

Course content:

• Regulatory framework for medical devices in the European Union
• General safety and performance requirements for medical devices
• Quality management system for medical devices
• Conformity assessment
• Post-market surveillance

After completing this course, you:

• are able to describe the regulatory pathway of a medical device from description of the intended purpose to placing into market and putting into service
• are 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
• are able to understand the main principles and challenges of vigilance system and post-market surveillance

More information in Tampere University’s study guide.