Real-time surveillance monitoring official releases, recall notifications, safety alerts, and guidance publications from US FDA (CDRH), CDSCO India, European Commission (EU MDR/IVDR MDCG), and MDSAP.
10
Total Notices
FDA CDRH: Medical Device & Radiation Health Guide CASRAI
openFDA: Guide to Medical Device APIs CASRAI
One-Third of 163 FDA-Cleared AI Medical Devices Got Algorithm Updates, but Most Reported No Clinical Benefit Data Medical Daily
European Commission expands list of well-established technologies under MDR RAPS
New pilot to support development of ‘breakthrough’ medical devices European Medicines Agency (EMA)
Pilot programme to be launched to support breakthrough medical devices and in vitro diagnostics European Commission
FDA CDRH: Medical Device & Radiation Health Guide CASRAI
openFDA: Guide to Medical Device APIs CASRAI
MDCG Guidance: EU MDR & IVDR Framework CASRAI
MDCG Guidance: EU MDR & IVDR Framework CASRAI
Automated regulatory surveillance engine aggregating official notices, guidances, and safety advisories across US FDA, CDSCO, European Commission, and Notified Body channels.
