Current location:Home > Strength > Quality Control
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》、ISO 13485:2016《Medical Device Quality Management System - Regulation System Section》、《Canadian Medical Device Quality Management System - Regulation System Section》、MDD 93/42/EEC《Medical Device Directive》、SOR/98-282《Canadian Medical Device Regulatory Requirements》、US 21 CFR PART 820 QUALITY SYSTEM REGULATION《FDA Medical Device Quality System Specification》、3.9B16《OEM Evaluation of the Conformity of Medical Devices》、RESOLUÇÃO - RDC No- 16, DE 28 DE MARÇO DE 2013(Quality System Certificate)
Process management
  • Incoming quality inspection
  • In process inspection
  • Finished products inspection
  • ISO13485