Development of test scheme and plan
Medical device testing is a process of verifying the conformity of the performance indicators of product samples and the attached product instructions and labels in the testing institution recognized by nmpa according to the product technical requirements (product registration standards) prepared by the enterprise.
For class II and III medical devices, the test report must be obtained from the testing institution approved by nmpa before registration, and the test report shall be submitted to nmpa for review as one of the main materials of the registration application; For class I medical devices, enterprise self-test report or third-party test report can be submitted at the time of filing.
Determination of test items
And applications for exemption items
Assist in contacting qualified
Laboratory and coordinate the testing process
Assist in drafting, formulating
Review product technical requirements
Assist in determining sample size
And sample inspection process services
Detection progress tracking
Technical communication in testing process