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2020-07-15
2020-07-20
2020-07-20
2020-07-20
2020-07-15
Development of test scheme and plan Consulting quotation 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 |