Regulatory & Quality
Ensuring Safety, Compliance and Excellence
Quality Assurance
At Wistron Medical Technology, we adhere to rigorous quality and regulatory frameworks that meet international standards. Our processes ensure product traceability, complete documentation, and readiness for audits at any time. With full confidence, our regulatory team provides technical documentation and global registration strategy support.
01
Regulatory Compliance
02
Continuous improvement of yield rates
03
Full traceability
04
Supplier quality management
International Certifications
QMS license
Quality Management System Certifications-Compliance with medical device quality management regulatory requirements
ISO 13485
Medical device quality management system standards
ISO 9001
International standards for quality management systems
IPC-A-610
Acceptability standards for electronic component soldering and assembly
