Authorized signatory to have the necessary professional knowledge and corresponding work experience; familiar with the scope of the authorized signature of the relevant testing, calibration standards, testing, calibration methods and testing, calibration procedures; able to test, calibration results to make a correct evaluation, understanding of the uncertainty of the measurement results.
Authorized Signatory conditions:
Have the necessary professional knowledge, familiar with the scope of the authorized signature of the relevant testing standards, testing methods and testing procedures and audit procedures, can make an accurate evaluation of the test results.
Served in a position responsible for the correctness of test results, with some experience in the management of medical device testing organizations.
Knowledge of accreditation methods, conditions of accreditation, and obligations of accredited medical device testing organizations.
Knowledge of the scope of the authorized signature of the maintenance and periodic calibration of test equipment regulations.
Authorized signatories have the following rights:
Have the right to approve the test report of medical devices within the scope of the authorized signature, and sign the report.
Have the right to supervise and guide the test personnel within the scope of the authorized signature of the test work.
The right to refuse to sign the test report does not meet the requirements.
Have the right to review the authorized signature range of test process documents to ensure their accuracy and completeness.