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
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.