YUANZAN
Quality

Quality System Certifications

Our manufacturing facility is dual-certified to ISO 9001:2015 Quality Management System and ISO 13485:2016 Medical Device Quality Management System standards, ensuring comprehensive systems and exceptional quality

Our quality management systems support consistent manufacturing, documentation control, and product evaluation based on applicable product categories and project requirements.

Certifications(4)

  • ISO 9001:2015 Quality Management System Certificate — Chinese VersionChinese version · 459 KB
  • ISO 9001:2015 Quality Management System Certificate — English VersionEnglish version · 473 KB
  • ISO 13485:2016 Medical Device Quality Management System Certificate — Chinese VersionChinese version · 450 KB
  • ISO 13485:2016 Medical Device Quality Management System Certificate — English VersionEnglish version · 470 KB

Test reports(1)

Product catalog(1)

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