Date & Time
Oct 27, 2022 11:00am CEST
Software classification of a medical device may not be an easy task for manufacturers, as they need to deal with multiple classification schemes with different requirements.
During the development of a product, these are three main points manufacturers should consider:
- If the device is a medical device.
- If the medical device can be considered a software as a medical device (SaMD).
- If the software is firmware just controlling hardware or if there is a higher level of data processing.
During this webinar, we will analyze medical product classification and software safety classification, provide an overview of the general requirements for IEC 60601-1 clause 14, the overlap with IEC 62304 and provide insights into the most common pitfalls.
Thanks to this webinar, regulatory affairs managers will learn about:
- General requirements of IEC 60601-1 clause 14 and the overlap with IEC 62304.
- Software classification rules according to IEC 62034, the purpose of the classification and examples of different classes.
- The use of segregation to reduce documentation efforts.
Sebastian Kern, engineering manager, UL Solutions
Krzysztof Wasilewski, project engineer, UL Solutions