Runde Medical is pleased to announce that the Quality Management System of Hengshui Runde Medical Instruments Co., Ltd. has been assessed and registered as conforming to GB/T 42061-2022 / ISO 13485:2016, the international quality management system standard for medical devices.
The certificate was issued by Shanghai POSI Certification Co., Ltd. on September 24, 2026, and is valid until September 23, 2029, subject to the required surveillance audits and continued conformity. The certificate registration number is 381260276R0S.
Achieving ISO 13485 certification marks an important step in Runde Medical’s ongoing quality development. It demonstrates that the company has established a structured quality management system for activities within the certified scope, with processes designed to support document control, supplier management, production control, inspection, traceability, risk-based decision-making, corrective action, and continual improvement.
The certified scope covers the production and sales of a broad range of medical support and fixation products, including back, shoulder, elbow, wrist, knee, and ankle braces; arm slings; pelvic fixation slings; external fixation braces and splints; stretchers; crutches; walkers; tourniquets; and medical positioning pads. It also includes specified export activities involving first aid kits, cervical collars, chest seals, hemostatic products, bandages, emergency blankets, and other emergency and rehabilitation supplies.
Since 2009, Runde Medical has focused on the manufacture and supply of first aid, trauma care, fracture immobilization, and patient transport products. With a 20,000-square-meter facility and 10 production lines, the company serves distributors, healthcare suppliers, emergency response organizations, and other professional buyers. Customization options are also available for packaging, logos, colors, sizes, and selected product configurations.
For customers and business partners, ISO 13485 certification provides added confidence that quality-related operations are managed through defined and auditable procedures. The certification applies to the company’s quality management system and should not be interpreted as certification of every individual product. Product-specific approvals, test reports, and market-entry documents remain subject to the product and destination market.
Runde Medical thanks its employees, customers, suppliers, and certification partners for their contribution to this achievement. The company will continue strengthening its quality system, manufacturing controls, and customer support to provide dependable medical and first aid solutions for global markets.
For certification details, product documentation, or partnership inquiries, please contact the Runde Medical team.
