IEI Achieves TFDA-QMS Approval and ISO 13485 Certification to Enhance MedTech Design Transfer

IEI Achieves TFDA-QMS Approval and ISO 13485 Certification

IEI Integration Corp., a leading global provider of medical and industrial computer platforms, has made significant strides in enhancing its manufacturing capabilities by successfully obtaining approvals that meet stringent international standards. On November 24, 2025, the company announced its acquisition of the Taiwan Food and Drug Administration (TFDA) Quality Management System (QMS) approval, along with the continuation of its ISO 13485:2016 certification. This accomplishment marks a pivotal moment for IEI as it reinforces its commitment to quality and regulatory compliance in the rapidly evolving MedTech landscape.

Strengthening Global Compliance

With the new certifications obtained for its facilities located in Xizhi and Qidu, IEI can now facilitate a smoother transfer of medical technology designs across borders. These approvals provide the company with the necessary framework to expedite the regulatory readiness of its Original Equipment Manufacturer (OEM), Original Design Manufacturer (ODM), and Contract Development and Manufacturing Organization (CDMO) clients. This ensures that medical products can be efficiently produced, evaluated, and brought to market, expediting timelines significantly in Asia, the USA, and Europe.

Kenny Jan, Senior Vice President of the Medical Business Unit at IEI, highlighted the importance of these certifications, stating, “The TFDA approval, in conjunction with ISO 13485, allows for smoother, more predictable audits, faster design transfers, and more reliable scaling in regulated markets.” This statement underscores the dual benefits of maintaining rigorous quality standards while meeting the diverse needs of clients across various regions.

Advanced Manufacturing Capabilities

IEI's campus in Qidu is already operating at impressive production rates, delivering approximately 38,000 printed circuit board assemblies (PCBA) and system units each month. This facility is designed to support rapid production launches and local order fulfillment, crucial components in meeting growing global demand. Additionally, IEI plans to expand its capabilities at their Taoyuan facility, aimed at further enhancing the scalability to meet future demand projections and optimizing regional logistics.

Key to IEI’s success is its innovative approach to manufacturing, which includes the implementation of smart factory technologies. For instance, they utilize advanced systems like Pick-to-Light material handling, automated counting of x-ray components, and automatic visual identification to ensure consistent and safe production scaling. Their commitment to integrating technology extends to comprehensive systems for traceability and quality assurance, significantly improving audit preparedness.

Compliance and Sustainability Framework

Operating under a unified governance model known as the “IEI Trust Stack,” the company employs a range of international standards, including ISO/IEC 27001 for information security, ISO 28000 for supply chain security, and IECQ QC 080000 for hazardous substance process management. This strategic alignment not only reduces validation times but also ensures continuous transparency in the production processes for medical technology brands.

The harmonization of national TFDA compliance with global ISO frameworks provides IEI's medical clients with a robust, audit-ready production base tailored for expansion across multiple markets. The ongoing dedication to regulatory compliance and operational excellence positions IEI as a pivotal player in the field of medical technology.

Looking Ahead

Founded in 1997, IEI Integration Corp. has established itself as a key player in the medical and industrial computing sector. Their expertise spans across design-to-manufacturing services, enabling secure and compliant MedTech, as well as Edge AI applications that respond to the growing demands of healthcare. The company’s focus remains on delivering advanced computing devices, networking solutions, and embedded platforms that meet high-quality standards backed by solid regulatory and cybersecurity measures.

For more comprehensive insights into IEI's offerings in medical technology, you can visit the IEI Medical Portal or explore their latest innovations at www.ieiworld.com/en.