So why is then a QMS needed at all?
Not only that it is demanded by the regulation MDR that processes need to be established, implemented and maintained, the MDR calls out explicitly for a QMS. To be clear here, the MDR does not call for ISO 13485, but generally for a QMS. This is, in fact, to assure that quality is managed and processes are implemented. These processes are needed not only for the development and bringing to market, but also for the market surveillance of the product and continuous improvement of the system itself.