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- Regulatory experts urge risk-based, lifecycle validation for AI tools in FDA workAt the RAPS AI in Regulatory Conference in Barcelona, a panel of experts discussed the growing use of AI tools by regulatory professionals. They recommended a risk-based, lifecycle approach to val…
- MDCG issues guidance on clinical evidence for orphan in-vitro diagnosticsThe Medical Device Coordination Group (MDCG) has published new guidance that explains how clinical evidence requirements apply to orphan in-vitro diagnostics (IVDs). The document is intended to he…