SHENZHEN MERICONN TECHNOLOGY CO., LTD

Quality Control

Authenticity verification includes but is not limited to the following situations. The verification of compliance and authenticity of the design and development process shall be comprehensive and objective.

(1)Product inspection samples, including the batch No. (No./Serial No., etc.) as well as specifications and models of the samples submitted for inspection, inspection time, inspection basis, inspection conclusion, key raw materials and/or components, calibration substances and/or quality control substances and other information, check whether sample photos, photos containing standalone software release version, labels and other information are consistent with the production batch records and whether they can be traced?

*Conform with requirements 

*Not conform with requirements

 (2) Are the clinical trial samples, including the batch No. (No./serial No., etc.) and specifications of the clinical trial samples consistent with the production batch records and can be traced back?

*Conform with requirements

* Not conform with requirements 

*Not applicable

(3) The batch of samples developed and produced and the production batch No. or product No., specification model/packaging specification, quantity of each batch, batch No. and quantity of samples submitted for inspection and clinical trial samples, batch No. and quantity of retained samples, production batch No. or product No. of existing samples and quantity, batch No. and quantity of main raw materials, etc. can be traced back?

* Conform with requirements

*Not conform with requirements

 (4) Do the original records of process inspection and factory inspection conform with the regulations of inspection procedures for design output and product technical requirements?

* Conform with requirements

*Not conform with requirements

 (5) If it is necessary to retain samples, could the retained samples be found, and the sample account and observation records of retained samples be kept?

*Conform with requirements

?Not conform with requirements 

*Not applicable

 (6) Whether to keep the procurement records of raw materials used for sample production, and the procurement records of raw materials recorded in the batch records used for sample production, such as raw material name, model specification, batch No., material (brand), supplier (manufacturer), quality standards and purchase acceptance, purchase vouchers, inbound and outbound records and account, etc.? The relevant information of the procurement record should be consistent with the content stated in the registration inspection report?

*Conform 

*Not conform with requirements