How to Tackle Medical Software Classification in 2022

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.

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.