EU Quality Management System Certificate (QMS)
The Notified Bodies follow the chapter I of Annex IX in MDR for the conformity assessment of the Qua...
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
The Medical Devices Regulation (MDR) provides several conformity assessment routes that medical devi...
PMS Medical Device
PMS Medical Device Post market activities are critical to generate clinical data regarding the medi...
ISO 13485 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...