Lifecycle-integrated comprehensive quality management
ensuring quality and compliance
We make sure that every product stands up to the rigorous global regulatory system by relying on international standards framework, whether for clinical-grade safety or mass-production consistency.
The core of our quality control capabilities:
International Certifications
ISO 13485、ISO 9001
Standards & Regulations Compliance
ISO 9001、ISO13485、GMP regulations、21CFR
820 (OSR820)、EU2017/745 (MDR), etc.
Full Process Oversight
Strictly monitor the whole process from design and development, procurement, in-process production control, product inspection and release, unqualified product control, change management, deviation management, CAPA and continuous improvement.
Cleanroom Environment
ISO 14644、ISO Class 7/8 cleanroom
Biocompatibility and Sterilization
ISO 10993 (Biocompatibility) 、ISO 11135 (Sterilization)
Risk Management
ISO 14971
