Location: Hilton Rotterdam, The Netherlands

Description: The unique challenges faced in earning approval for medical software products require a different approach from other medical devices. In addition, cybersecurity concerns and the rise of artificial intelligence bring new regulations and guidance documents published on a weekly basis. This in-person even will look at the history and current state of play of software as a medical device (SaMD). Global requirements will be discussed, including the EU and US regulations, along with:

• How to determine when software is considered regulated as SaMD
• How to determine the correct class/classifications under global requirements
• Software lifecycle management and performing risk assessment.

In addition, practical case studies will be presented for each subject.

Organiser: RAPS

Contact: https://www.raps.org/events/software-as-a-medical-device-02-2022