Quality Assurance: Scientific Management, Quality First, Safety & Effectiveness, Technical innovation

The company strictly abides by the following laws and regulations:
Quality Management Standards for Medical Devices,
IS0 13485:2016 lledical Device Quality lanagement System - Regulation System Section
MDD 93/42/EEC Medical Device Directive
US 21 CFR PART 820 QUALITY SYSTEM REGULATION FDA Medical Device Quality System Specification
3.9B16 OEM Evaluation of the Conformity of Medical Devices