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Medical Devices regulatory Affairs
Clario’s SpiroSphere® with wireless ECG- FDA clears, simplifying clinical trial data collection. Clario’s SpiroSphere The FDA has granted 510(k) clearance…
DSCSA (Drug Supply Chain Security Act): FDA extends on 24 DSCSA tracking rules for small dispensers by two years and…
Medical device equipment: The report suggests strategies to enhance accessibility and cost-effectiveness of crucial medical device equipment. Medical device equipment…
Device surveillance the European Union’s Medical Device Coordination Group (MDCG) has released revised guidance on device surveillance. Device surveillance The…
Introduction to CMC Compliance for Medical Devices Introduction to CMC (Chemistry, Manufacturing, and Controls) compliance is a critical factor in…
Risk management for medical device and pharmaceuticals Risk management, to guarantee the security and effectiveness of medical equipment and prescription…