Tag: AI in Healthcare

Medical Devices – Europe, Asia and ROW Regulatory News – July 2025

Medical Device

BRAZIL Brazil Implements UDI Labeling for Class IV Medical Devices In July, Anvisa marks significant progress in the implementation of Unique Device Identification (UDI) in Brazil, requiring...

AI in Healthcare, EU MDR, HSA Singapore, IVD Devices, Medical Device Regulation, PMDA Japan, PSUR, Regulatory Compliance, SaMD, UDI Brazil

European Health Data Space’s implications for “Wellness Apps” & Medical Devices

Medical Device

The European Health Data Space is a health specific ecosystem comprised of rules, common standards and practices, infrastructures and a governance framework that aims at: 1. Empowering individuals...

AI in Healthcare, Digital Health, Electronic Health Records (EHR), GDPR Compliance, Health Data Security, HealthTech Regulations, Medical Devices, Preventive Healthcare, Wellness Apps