Ultrasound Soft Tissue Surgical Equipment Includes Main Engine, Transducer, Surgical Instruments, And Foot Switch. Will It Be Possible To Add Convertor Through Changes To Registration So That The Transducer And Surgical Instruments Can Be Connected Into Other Manufactures’ Main Engine?

2022-10-30

The compatibility of main engine, transducer and surgical instruments of ultrasound soft tissue surgical equipment will have great influence on the product safety and effectiveness. The design and development of each part needs to be considered as a whole system.

Even if there is sufficient verification and validation on the compatibility with approved product from other manufacturers during design and development, while still not able to timely grasp the design change and carry out systematic analysis, then it will result in the introduction of safety and effectiveness risk due to the compatibility problem.

Therefore, if the administrative counterparts have clear cooperative relationship with the other manufacturers so as to ensure the product design changes between each other can be systematic analyzed, it is possible to apply. If not, the application will not be possible.

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