Lumigenex (Suzhou) Co. Ltd quality control

Lumigenex owns a 100,000-level purification workshop, complete quality management control system, and production license for Class II medical devices and Class III IVD reagents. We also passed ISO13485 system certificate, and own CE certification for many products.
In terms of quality control, it includs multiple aspects, such as:
1. Regular maintainance of production equipment, as well as good records
2. Annual verification of key equipment
3. The raw material inspection records are classified and archived according to category, semi-finished and finished product inspection records are archived according to product items and batches, and the production records are archived accordingly
4. Purchase: Review and evaluate suppliers, conduct on-site audits when necessary, and sign a quality agreement with the suppliers after passing the audit to clarify the quality responsibilities of both parties
5. Sales: establish product sales records for traceability
6. Carry out management review annually