Tag: HPRA

Medical Devices-USA/Europe Regulatory News-July 2023

July 11, 2023
Medical Device

USA (FDA) Content of Premarket Submissions for Device Software Functions The purposes of this document, FDA refers to a software function that meets the definition of a device as a device software...

Europe Regulatory News, FDA, HPRA, Medical Devices, MHRA, Premarket Approval (PMA), Regulatory News, USA Regulatory News

Medical Devices-USA/Europe Regulatory News – April 2023

April 4, 2023
Medical Device

USA (FDA) Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act-Guidance for Industry and Food and Drug Administration...

Europe Regulatory News, FIMEA, HPRA, Medical Devices, MHRA, Regulatory News, Swissmedic, US FDA, USA Regulatory News

Medical Devices-USA/Europe Regulatory News – March 2023

March 2, 2023
Medical Device

USA (US FDA) Laser Products – Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56)-Guidance for Industry and Food and Drug Administration Staff The guidance...

Canada Regulatory News, Europe Regulatory News, FIMEA, HPRA, Medical Devices, MHRA, Regulatory News, Swissmedic, US FDA, USA Regulatory News