Über die Veranstaltung

Keywords:
- Regulatory basics for software
- Software as medical device or as part of a medical device
- Software Safety classification
- Software life cycle according to IEC 62304

Description:
This course introduces the regulatory fundamentals for medical device software, including the distinction between software as a medical device (SaMD) and software as part of a medical device. Participants will learn about software safety classification and its regulatory implications. The course also covers the software lifecycle in accordance with IEC 62304, providing a structured framework for compliant development and maintenance.