We implement ISO 13485:2003 Quality Management System in our whole operations, and have five QC staff to control the quality of the whole production process, which includes incoming raw material checking, stitching process checking, assembly process checking, final packing checking and quality checking before shipment. All of our products are CE-certified and FDA-approved.
Our principal is "Customer's Satisfaction Is Quality". Therefore, we dedicate in carrying out all kinds of quality improving policies to achieve final goal - 100% customer's satisfaction.
In order to maintain the steady of our products' quality, we strictly implement quality control based on the requirement of ISO 13485:2003 Quality Management System, we strictly request all of our staffs and production crew to input all the effort to practice the quality management spirit and ways. And strict standard are used to audit every product come out from our production lines.
Scope/Range:Medical Device Directive 93/42/EEC
Issued By:ISET S.R.L
Scope/Range:Quality Management System
Issued By:National Quality Assurance Limited