Please note that a separate fee is required to attend this pre-conference workshop and is not included in the main registration for the 2021 Euro Convergence. If you have already registered for the conference and would like to add this workshop, please contact email@example.com or log in to the registration system and modify your registration. Registration closes on 5 May at 23:59 CEST. CLICK HERE TO REGISTER
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.