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
Finished Products Inspection