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The regulation and market approval of Drug Device Combination Products (DDCPs) in Europe is a specialized and intricate process due to the combined nature of medicinal and device components. Manufacturers are required to seek a Notified Body Opinion (NBOp), which is a component of the conformity assessment for the EU Medical Device Regulation (MDR)2017/745, when …

How to Get Notified Body Opinion Report for Drug Device Combination Products in Europe Read More »

QMS is a set of interconnected elements (Quality Policy, Procedures, Manual, Work Instruction, Records) that directs and controls the organization in consistently meeting customer requirements and enhancing their satisfaction. What is quality management systems? The quality Management System is a framework organizations use to ensure consistency in delivering products, services, and processes that satisfy or …

Types of quality management systems Read More »