Watch now: How to tackle medical software classification in 2022
During this webinar, we 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.
Oct. 27, 2022
Sebastian Kern, engineering manager, UL Solutions
Krzysztof Wasilewski, project engineer, UL Solutions
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.
Thanks to this webinar, regulatory affairs managers learn about:
- General requirements of IEC 60601-1 clause 14 and the overlap with IEC 62304.
- Software classification rules according to IEC 62304, the purpose of the classification and examples of different classes.
- The use of segregation to reduce documentation efforts.