A Quality Management System (QMS) is a structured framework that records processes, protocols, and duties to attain quality goals and directives. It aids in arranging and guiding an organization’s operations to fulfill customer and regulatory standards while enhancing efficiency and effi

The European Union (EU) medical device market stands as one of the largest and most stringent globally. Manufacturers face the challenge of adhering to complex regulations, notably the EU Medical Devices Regulation (MDR) (2017/745) and the EU In Vitro Diagnostics Regulation (IVDR) (2017/74