Management System Certification

1. Our company is a third-party certification body accredited by CNAS, with the qualification to issue ISO 13485 quality management system certificates; 2. We provide ISO 13485 system consulting and special QMSR 820 guidance, helping enterprises establish, improve and implement a quality management system, ensure the compliant and effective operation of the system, and successfully pass the audit.

Authoritative certification qualification: As a CNAS-accredited third-party certification body, our certificates are globally recognized and meet the market access requirements of all countries; Full-chain consulting capability: We provide one-stop full-process service from system establishment, document compilation, operation guidance to audit and certification, covering special requirements including ISO 13485 and QMSR 820; Deep industry experience: We have been deeply engaged in the medical device industry for many years, are familiar with system control points for all product categories such as active devices, passive devices, IVD, etc., with a high guidance passing rate; Continuous compliance guarantee: After certification, we provide annual supervision audit, system upgrade guidance, and regulation update training to ensure the continuous compliant operation of the system.