Quality & Compliance

Quality & Compliance

BrosMed Medical has established a high-standard quality management system that meets global standards.

At BrosMed, quality is more than a requirement—it is a responsibility we uphold to safeguard patient health and well-being. Delivering safe, reliable, and effective products is the foundation of everything we do. We operate a comprehensive Quality Management System (QMS) designed to meet international standards and regulatory requirements, including ISO 13485, China's Good Manufacturing Practice (GMP) for Medical Devices, U.S. FDA 21 CFR Part 820, and Japan MHLW Ministerial Ordinance No. 169. Our commitment to quality and compliance is demonstrated through successful inspections and audits by leading regulatory authorities and notified bodies, including the NMPA, FDA, PMDA, BSI, and TÜV. Reflecting our sustained excellence in quality management, BrosMed has been recognized as a Class A Quality Credit Medical Device Enterprise in Guangdong Province for five consecutive years. Driven by a culture of quality, compliance, and continuous improvement, BrosMed is committed to delivering products that help improve patient outcomes worldwide.

All
  • All
  • Product Management
  • News
  • Introduction
  • Enterprise outlets
  • FAQ
  • Enterprise Video
  • Enterprise Atlas