The Australian medical device regulatory division TGA has release a new online tool to assist manufacturers with classifying their products.  The SME Assist tool “is a dedicated service that TGA offers to help small to medium enterprises (SMEs), researchers, start-ups and those unfamiliar with regulation to understand their regulatory and legislative obligations.”Read More

Company: GE Healthcare Finland Oy Date of Enforcement Report 10/17/2018 Class II: PRODUCT GE Healthcare CARESCAPE Monitor B450 Recall Number: Z-0095-2019 REASON When multiple CARESCAPEMonitor B450 or B850 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restart will not...Read More