Category: Medical Devices

Clarios SpiroSphere® with wireless ECG- FDA clears, simplifying clinical trial data collection. Clarios SpiroSphere The FDA has granted 510(k) clearance for the COR-12 wireless ECG device, now seamlessly integrated with SpiroSphere®. This integration enables...

DSCSA (Drug Supply Chain Security Act): FDA extends on 24 DSCSA tracking rules for small dispensers by two years and allows exemption requests. DSCSA (Drug Supply Chain Security Act): On Wednesday, the US Food...

Medical device equipment: The report suggests strategies to enhance accessibility and cost-effectiveness of crucial medical device equipment. Medical device equipment Encouraging the local production of vital medical equipment, establishing a reliable logistics network and...

Device surveillance the European Unions Medical Device Coordination Group (MDCG) has released revised guidance on device surveillance. Device surveillance The Medical Device Coordination Group (MDCG) has recently issued an updated version of its Surveillance...

Introduction to CMC Compliance for Medical Devices Introduction to CMC (Chemistry, Manufacturing, and Controls) compliance is a critical factor in the development and approval of medical devices. The CMC regulatory framework ensures that medical...