Regulatory Aspects for Medtech Products

What it is about

You will learn the regulatory requirements for the approval of medical devices in the EU, in particular the contents and consequences of the Medical Device Regulation (MDR). By the end you will be able to apply regulatory requirements to development processes, classify technical documentation, and evaluate products with regard to functional safety, IT security, and KI-related questions.

What you will be able to do

• Apply regulatory prerequisites for approval
• Apply requirements for technical documentation in the development process
• Analyze questions about artificial intelligence in medical devices
• Evaluate medical devices with regard to functional safety and IT security

What the module consists of

• LectureConveying the content and explaining it using case studies

Teaching method

• Lecturefor introduction and explanation of the regulatory content
• Case studiesfor applying what has been learned to concrete situations
• practical demonstrations and digital mediawhere possible to illustrate the case studies