Tag: CE marking

Medical Devices-USA/Europe Regulatory News-September 2023

September 6, 2023
Medical Device

USA (FDA) Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors The guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors...

CE marking, Europe Regulatory News, in vitro diagnostics, Medical Devices, Regulatory News, USA Regulatory News, vigilance