IEI Integration Corp. Achieves TFDA Quality Management Approval and ISO 13485 Certification

IEI Integration Corp. Earns Quality Management Approval and ISO Certification

IEI Integration Corp. (often referred to as IEI) has recently announced a significant milestone by securing approval from Taiwan's Food and Drug Administration (TFDA) for its Quality Management System (QMS) along with maintaining its ISO 13485 certification for 2016. These achievements not only bolster IEI's reputation as a leading provider of medical and industrial computing platforms but also ensure that its manufacturing processes are ready for audits, particularly for the critical sector of medical technology.

The company operates out of its state-of-the-art facilities in New Taipei City (Xizhi) and Keelung (Qidu), both of which have successfully passed rigorous inspections conducted by the TFDA. This dual certification—QMS approval (Xizhi Cert No. QMS2376, Keelung Cert No. QMS2377) and ISO 13485—positions IEI as a frontrunner among Taiwanese manufacturers possessing both local and international quality credentials. These certifications streamline design transfer processes and regulatory compliance, allowing IEI's clients to more efficiently navigate the complexities of bringing medical products to market across various regions including Asia, the United States, and Europe.

Kenny Jan, Senior Vice President of IEI’s Medical Business Unit, emphasized the dual approval's impact on the company's operational efficiency: “The overlap of TFDA approval with ISO 13485 allows for smoother and more predictable audits, faster design transitions, and reliably scalable operations in regulated markets.” This sentiment underlines the strategic advantages that come with maintaining stringent quality standards.

IEI supports Original Equipment Manufacturers (OEMs), Original Design Manufacturers (ODMs), and Contract Development and Manufacturing Organizations (CDMOs) by expediting the compliance process. Their advanced production capabilities include the monthly output of 38,000 units of printed circuit board assemblies (PCBAs) and system units from the Qidu campus alone, laying a robust foundation for rapid production expansion and regional distribution.

Furthermore, to meet anticipated demand and enhance logistics, IEI is planning to increase its manufacturing capacity in Taoyuan, gradually expanding operations to accommodate future projects.

The company has also adopted highly automated smart factory tools as part of its operations. These tools include systems for material handling, using pick-to-light technologies, component counting via X-rays, and automatic visual identification, all aimed at stabilizing production launch phases. Coupled with robust production monitoring systems, such as Manufacturing Execution Systems (MES) for traceability, Automated X-ray Inspection (AXI), and corrective and preventive action (CAPA) documentation, IEI reinforces its audit readiness.

Operating under a unified governance model known as the “IEI Trust Stack,” the company’s smart factory adheres to industry standards including ISO 13485/TFDA, along with ISO/IEC 27001 (data security), ISO 28000 (supply chain security), IECQ QC 080000 (process governance for hazardous substances), and ISO 14064-1 for greenhouse gases. This comprehensive framework facilitates quicker validation timelines, simplifies audit processes, and provides comprehensive transparency across medical technology brands.

By aligning compliance with national TFDA standards and international ISO frameworks, IEI delivers a transparent, audit-ready manufacturing base for its pharmaceutical clients, further positioning itself for global expansion.

About IEI Integration Corp.

Founded in 1997, IEI Integration Corp. has established itself as a prominent global provider of medical and industrial computing platforms, along with CDMO/ODM services. With a focus on facilitating regulated applications in medical technology and edge AI, the company integrates advanced technologies in medical computing, network devices, and comprehensive system platforms, all supported by strong quality assurance frameworks and cybersecurity measures. For more information on IEI's medical technology offerings, visit the IEI Medical Portal.

Visual Content

For those interested, IEI has also made available a video showcasing its extensive medical computing product range, which includes Medical Panel PCs, AI Box PCs, Medical Monitors, and solutions designed for clinical environments. The video demonstrates IEI's expertise in edge AI, medical imaging, and intelligent healthcare integration, aimed at delivering reliable technologies for the future of healthcare.