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:

1. If the device is a medical device.
2. If the medical device can be considered a software as a medical device (SaMD).
3. 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.

Speakers:
Sebastian Kern, engineering manager, UL Solutions
Krzysztof Wasilewski, project engineer, UL Solutions