About this document
AI/ML Regulatory Update in Life Sciences by Sasa Vujovic is a document available to read on EtoBox.
The document provides an update on the global regulatory and standards landscape for AI/ML. It discusses the current regulatory landscape for AI/ML in life sciences, guidelines for registration of AI medical devices from the FDA, and a deeper dive into Chinese NMPA AI guidance. It also discusses using existing frameworks like IEC 62304 and ISO 14971 for AI/ML product development and a modified AAMI/ISO TIR80002-2:2017 workflow for iterative risk analysis and validation.
- Author
- Sasa Vujovic
- Language
- EN