Credo Diagnostics Biomedical Pte. Ltd. Taiwan Branch

Ensuring the devices for performance study to conform to the general safety and performance requirement and every precaution has been taken to conform to protect the health and safety of subject, and the correlation statement is issued. The technical documentation and Declaration of Conformity of EU and other countries kept up to date.

Ensuring that QMS requirements are established, implemented, maintained, and sustained. Reporting on the performance of the QMS to us to review and identify actions and opportunities for quality improvement. The technical documentation and DoC of EU and other countries kept up to date. The PMS, Vigilance Reporting obligations are complied, in accordance with the appropriate regulatory requirement. Coordinating with various units on matters relating to the organization’s QMS.