May 07, 2021 - May 07, 2021
Date: 7th of May 2021
Time: 8.45 - 17.00 CET
Qserve Attendee: Gert Bos, workshop leader
This workshop will review the current and evolving regulatory requirements for Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), and Medical Device Software (MDSW). The speakers will focus, in particular, on artificial intelligence-based medical devices.
Navigating the expectations for software products is challenging and requires a different approach from other medical devices. Issues to be addressed include determining what software is subject to medical device legislation, its class, differences across the world, and common challenges, pitfalls, and solutions for gaining market authorization.
Market authorization poses significant hurdles for software manufacturers but getting digital technologies and AI-based medical devices into the care pathways can be even more challenging. This workshop explores solutions for gaining user trust and achieving market adoption.
The session will include practical case studies to work through completing the required assessments. This workshop will be particularly beneficial to regulatory professionals, QA professionals, and application developers responsible for managing and planning regulatory compliance and market access for digital technologies.
Gert Bos will attend a panel discussion from 13.55 until 14.35 CET regarding 'How to mitigate and prevent flaws and pitfalls' and 'Guidance and standardization needs'. For more information about the Pre-Conference Workshops, please visit the RAPS website.