This presentation will explore the critical challenges of data integrity and accessibility within the context of AI-powered, FDA-regulated medical devices. It will delve into the importance of robust and reliable data for the development, validation, and ongoing performance of these technologies while ensuring compliance with HIPPA and the General Data Protection Regulations (GDPR) in the EU. The session will highlight key concerns related to data quality, bias, security, and provenance (under data integrity), as well as the difficulties in accessing diverse datasets, navigating privacy regulations, and facilitating data sharing (under data accessibility). The presentation will emphasize the potential impact of these issues on patient safety and regulatory compliance.
This is the fourth presentation from day 2 of the live 3-day virtual symposium hosted through the Sotera Academy where Industry experts from Nelson Labs, Sterigenics, and Regulatory Compliance Associates (RCA) take you through a virtual symposium exploring the full product lifecycle of connected and wearable medical devices. From R&D and product design to sterilization, regulatory approval, and launch — this recorded session covers the critical considerations that can make or break the success of your connected device. Click here to watch all of the presentations on the Sotera Academy or fill out the form on this page for access.