LATEST BLOGS US FDA PREMARKET APPROVAL (PMA) ByBiomedical Views June 25, 2025 US FDA US FDA De Novo Submission ByBiomedical Views June 25, 2025 US FDA US FDA Premarket Notification 510(k) ByBiomedical Views June 25, 2025 US FDA EU MDR Certificates issued by Notified Body ByBiomedical Views July 31, 2024 EU MDR 2017/745 EU MDR Procedure for Custom-Made Devices ByBiomedical Views April 28, 2024 EU MDR 2017/745 EU MDR Instructions for use ByBiomedical Views March 28, 2024 EU MDR 2017/745 EU MDR Scrutiny Procedure ByBiomedical Views February 3, 2024 EU MDR 2017/745 EU MDR Clinical Investigation ByBiomedical Views December 29, 2023 EU MDR 2017/745 IEC 62304 Software Configuration Management & Problem Resolution ByBiomedical Views November 30, 2023 IEC 62304 IEC 62304 Software Maintenance Process ByBiomedical Views October 29, 2023 IEC 62304 IEC 62304 Software System Testing ByBiomedical Views September 23, 2023 IEC 62304 IEC 62304 Software Unit Implementation and Integration ByBiomedical Views August 5, 2023 IEC 62304 12345›»
