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...
Control of Outsourced Processes Procedure
(EN) ISO 13485:2016 Control of Outsourced Process is manufacturer’s responsibilities don’t chang...
Non Conformity (NC)
Non Conformity in ISO 13485 Certification Body Audit A major nonconformity is can be a failur...
Medical Device Post Market Surveillance
Medical Device Post Market Surveillance is normally performed after the medical device is released i...