@dgrainger , as you indicated, manufacture and use under appropriate quality management systems.
Let's analyse: Manufacturer: the devices made by the health institute shall be manufactured... For that a QMS is needed comparable to device manufacturers, ensuring traceability and identification of all steps. ISO 13485 can be used, but complete ISO 13485 might be overkill.
Regarding use, this Regulation requires that health institutes uses these devices under an appropriate QMS. As control over these requirements is falling under country competent authority responisibilities, what is deemed appropriate can differ per country. To get an understanding of what appropriate might mean, get in contact with for example hospitals and see what procedures are in place regarding use of medical devices. For example in the Netherlands, a convenant has been set-up several years ago, defining how medical devices during the life time of use are implemented, training on, maintained, disposed of etc. in hospitals.
So more QMSs, relevant for healthacare institutes can be applicable.