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Oct 27, 2022
  • Webinar

How to Tackle Medical Software Classification in 2022

The webinar will cover medical product classification and software safety classification, providing an overview of IEC 60601-1 clause 14, the overlap with IEC 62304 and insights into common pitfalls.

Doctor using tablet and other electronic devices for patient

Date & Time

Starts

Oct 27, 2022 11:00am CEST

Ends

12:30pm CEST

Location

Online

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