Clinical Investigations of Medical Devices
Clinical investigations of medical devices carried out in human subjects to assure the safety and pe...
CE Marking for Surgical Gowns and Drapes
Is CE Marking for Surgical Gowns and Drapes Mandatory for exporting to Europe? Is the Surgica...
EU Declaration of Conformity Medical Device
EU Declaration of Conformity Medical Device states that the requirements specified in the regulation...
MDR Conformity Assessment Routes
Chapter V section 2 of MDR Conformity Assessment Routes based on article 52. Conformity assessment r...
PMS of Medical Device
PMS of Medical Device Post market activities are critical to generate clinical data regarding the m...
Medical Device Biocompatibility
Medical Device Biocompatibility depends on device risk class and each risk the test procedur...
Control of Outsourced Processes Procedure
(EN) ISO 13485:2016 Control of Outsourced Process is manufacturer’s responsibilities don’t chang...