Ultrasound soft tissue surgical equipmentincludes main engine, transducer, surgical instruments, andfoot switch.Will it be possible to add convertor throughchanges to registration so that the transducer and surgicalinstruments can be connected into other manufacturesmain engine?
1 回答
The compatibility of main engine, transducer and surgicalinstruments of ultrasound soft tissue surgical equipment will havegreat influence on the product safety and effectiveness. The designand development of each part needs to be considered as a wholesystem.
Even if there is sufficient verification and validation on thecompatibility with approved product from other manufacturersduring design and development, while still not able to timely graspthe design change and carry out systematic analysis, then it willresult in the introduction of safety and effectiveness risk due to thecompatibility problem.
Therefore if the administrative counterparts have clear cooperativerelationship with the other manufacturers so as to ensure the productdesign changes between each other can be systematic analyzed, it ispossible to apply. If not, the application will not be possible.
