• Regulatory framework for medical devices in the European Union
• General safety and performance requirements for medical devices
• Classification of medical devices
• Technical documentation
• Risk management system (standard EN ISO 14971)
• Clinical evaluation and performance evaluation
• Post market surveillance system and vigilance
• Quality management system (standard EN ISO 13485)
• Conformity assessment procedures and the role of the conformity assessment bodies
• Registration requirements and European medical device database (EUDAMED)

 After completing this course, you: 

• are able to follow the constantly changing EU regulatory framework for medical devices
• 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 (MD) or performance evaluation (IVD)
• are able to understand the main principles of a post-market surveillance system and challenges of vigilance system
• can explain the main elements of a quality system covering design and manufacture 
• are able to select a conformity assessment procedure based on classification rules and chose a conformity assessment body