To strictly control the product quality, we manage and organize the production in full compliance with the ISO13485 : 2016 and FDA. We focus on all aspects that may influence the product quality, and consistently follow the strict craft discipline.
Strict Purchase Management of the Raw Materials
When purchasing the important rawmaterials, we merely choose the qualified manufacturers as our suppliers. Only the materials that have been inspected to be qualified can be put into storageor can be used. In addition, we regularly evaluate the performance of the suppliers.
Control and Inspection of Outsourcing Manufactured Parts
We will inspect the outsourcing manufactured parts and have signed a quality assurance agreement and only the qualified ones that can be put into the warehouse.
Those machines will be treated with the regular maintenance. Most of them are high precision machines with high degreeof automation. There are more than 80 sets of machines mainly imported from Europeand America, including DMG MORI AKTIENGESELLSCHAFT five axis processingcenters (Germany), Precision Machine Tool Equipment from Haas Automation (US), Medium-speed Wire Cut Electrical Discharge Machining from AGIE (Switzerland) or Precision Five-spindle Grinding Machine from Schütte (Germany), etc. Besides that, we also have a complete set of inspection and measuring equipment, including ChromatographImported from Japan, High-end Universal Testing Machine Imported from US, Precision Moisture Meter Imported from Switzerland and Precision Moisture Meter Imported from Switzerland.
Highly Skilled and Experienced Staff
40% of the staff are the technicians who have college degrees or above. The operators and inspectors, who are responsible for the special or critical production processes, will receive the pre-service training. They must take the appointment with certificates. Moreover, regular on-the-job training will be conducted for them.
Standardized Quality Management
We arrange the production in line with the CFDA Good Manufacturing Practice. The control of the critical production process and special process has been strengthened. The records about the production and inspections will be made, which allows for the traceability.
Good Production and Storage Environment
The fully equipped factory is capacious, clean, and bright. It is built with a 2000 square meters clean room, which has the cleanness of Grade 100,000. In this clean room, we carry out such processesas cleaning and initial packing for the disposable sterile medical devices and orthopedic implants. Good storage conditions are available. The warehouses are rationally arranged. They are separately used for the raw materials, hardware, finished products, etc.