Quality Management System (QMS)

Manufacturer/ Dealers: (ISO13485, QSR, GDPMD, QMS, GMP)

ARQon develop a quality system documentation for certification for company to comply with the internationally recognised quality system standards and requirements such as:

• ISO 13485 Medical devices, Quality management systems, Requirements for regulatory purposes
• United States: Quality System Regulation (QSR) Part 820
• European Union: Medical Device Directive (MDD)
• Good Distribution Practice for Medical Device (GDPMD)
• Good Manufacturing Practice (GMP)