Digitalisation is increasing the relevance of software solutions in the medical field, particularly in terms of diagnosis and therapy. These technologies enable faster, more precise analysis of medical data and support complex decision-making processes. Medical software optimises workflows and increases efficiency through automation and extensive databases that enable faster disease detection and treatment.

 you will be able to explain why medical software is subject to strict regulatory requirements and how these affect patient care.
  you will understand the importance of CE registration in ensuring the safety and effectiveness of software.
  you will be able to explain how CE registration confirms that medical software fulfils essential requirements for safety, performance and reliability.
  you will understand how compliance with these requirements increases confidence in the safety and effectiveness of the software and improves patient care.
  you will be able to recognise the growing importance of medical software in the healthcare sector due to the need for efficient diagnostic and therapy support tools.
  you will understand why CE registration is critical to ensure the highest quality standards for these software solutions.
  you will be able to explain what tasks authorised persons have. you will know the conformity assessment procedure.
  you will know the three process types of the quality management system.
  you will understand why registrations, UDI and Eudamed are crucial for the market launch.
  you will be able to describe what post-market surveillance involves.