ABSTRACT
Percutaneous renal puncture device has very important clinical value. Qualified percutaneous renal puncture device is one of the important ways to evaluate its safety and efficacy, and it is also an important prerequisite for the device to be marketed in China. When manufactuers test the product, the selection of representative products is suggested from the aspects of performance parameter, structure, material and production process.
Subject(s)
Humans , China , Kidney , Nephrostomy, Percutaneous , PuncturesABSTRACT
There is no corresponding product standard and industry standard for the search and development of magnetocardiograph at home and abroad. In this paper, based on the working principle and clinical application function of magnetocardiograph, and on the basis of relevant regulations and normative documents of medical device registration, some thoughts and concerns about the technical review of this kind of product are put forward.