IEI Integration Corp. Receives TFDA QMS Approval and ISO 13485 Certification for Enhanced MedTech Manufacturing

IEI Strengthens MedTech Manufacturing with QMS Approval

Overview of Achievements

On November 24, 2025, IEI Integration Corp., a global supplier of medical and industrial computing platforms, announced significant advancements in its manufacturing processes. The company has successfully passed inspections by the Taiwan Food and Drug Administration (TFDA) for its facilities in New Taipei City and Qidu, receiving official Quality Management System (QMS) approval along with retaining its ISO 13485:2016 certification. This impressive dual certification positions IEI as a leading player in the global medtech manufacturing landscape.

Significance of QMS and ISO 13485

The combination of TFDA QMS approval and ISO 13485 certification is pivotal for manufacturers in the healthcare sector. These certifications facilitate smoother design transfers and ensure regulatory compliance, which are essential for companies looking to operate across various markets including Asia, the USA, and Europe. Kenny Jan, Principal Vice President of the Medical Business Unit at IEI, elaborated on the advantages: “The approval streamlines audits and accelerates design transfers, leading to a more reliable scaling process in regulated markets.”

Manufacturing Capabilities

IEI operates production facilities that are capable of manufacturing 38,000 units of Printed Circuit Board Assemblies (PCBA) and 38,000 system units each month. This robust output allows for quick responsiveness to market demands. Furthermore, the company is planning additional capabilities in Taoyuan to meet anticipated demand and enhance localized logistics. The integration of smart factory tools such as pick-to-light material handling, X-ray component counting, and automatic visual identification contributes to the stability and reliability of production processes.

Future Partnerships and Applications

With the newly acquired certifications, IEI is prioritizing partnerships in the Contract Design and Manufacturing Organization (CDMO) space, particularly focusing on medical imaging peripherals, vital signs monitoring, and endoscopy and radiology integration. This strategic move is expected to expedite the clinical utilization of compliant designs, thus fostering innovation in the healthcare sector.

Implementing Smart Manufacturing Solutions

In response to the market’s increasing demands, IEI has introduced a highly automated suite of smart factory tools designed for efficient production scaling, particularly for Class II endoscopy devices targeted at the European market. Investments in traceability systems linked to MES (Manufacturing Execution System), automated inspection technologies, and documented corrective actions and preventive actions (CAPA) have further enhanced its readiness for FDA audits.

A Unified Governance Model

IEI adheres to a unified governance model referred to as the “Trust Stack,” ensuring that its smart factory maintains ISO 13485 compliance as well as other critical standards such as ISO/IEC 27001 for information security, ISO 28000 for supply chain safety, IECQ QC 080000 for governance over hazardous substances, and ISO 14064-1 for greenhouse gas emission accounting. These broad-ranging compliance measures underscore the transparency and integrity of IEI’s manufacturing operations.

Commitment to Transparency and Expansion

By aligning national compliance with global ISO frameworks, IEI offers its clients in the medical field a solid foundation for manufacturing that is transparent, verifiable, and geared towards expansion in diverse markets. As the company continues to forge ahead with its robust manufacturing capabilities and strategic partnerships, it is poised to play a pivotal role in shaping the future of the medtech industry.

Conclusion

IEI Integration Corp.'s accomplishments in securing TFDA QMS approval and maintaining ISO 13485 certification not only reinforce its commitment to quality and regulatory compliance but also elevate its competitive edge in the medical technology sector. The company's focused efforts towards enhancing production capabilities and partnerships signify a forward-looking approach to addressing the evolving needs of the healthcare market.