IEI Secures TFDA QMS Approval and ISO 13485 Certification, Reinforcing Audit-Ready Manufacturing for MedTech Design Transfers

Dual certifications streamline global design transfers and regulatory compliance.

TAIPEI, Taiwan — November 24, 2025 IEI Integration Corp. (“IEI”), a global provider of medical and industrial computing platforms, today announced that its New Taipei City (Xizhi) and Qidu (Keelung) facilities have passed inspection by the Taiwan Food and Drug Administration (TFDA) and been awarded Quality Management System (QMS) approval (Xizhi Certificate No. QMS2376、Keelung Certificate No. QMS2377), while maintaining ISO 13485:2016 certification. As one of Taiwan’s manufacturers holding both domestic and international medical QMS credentials, IEI enables OEM/ODM/CDMO clients to accelerate regulatory readiness and scale production across Asia, the United States, and Europe.

Backed by TFDA Class II credentials, IEI is prioritizing CDMO partnerships in medical imaging peripherals, vital-sign monitoring, and endoscopy/OR integration—bringing compliant designs to clinical use faster.

IEI’s Qidu (Chi-Du) campus delivers 38K PCBA units per month and 38K system units per month, supporting rapid ramps and regional fulfillment. Additional capacity in Taoyuan is under planning, with a phased build-out to support forecast demand and regionalized logistics

Layering TFDA approval on top of ISO 13485 enables smoother, more predictable audits, faster design transfers, and more reliable scale-up in regulated markets. Senior Vice President of IEI’s Medical Business Unit. - Kenny Jan

For a Europe-based Class II endoscopic device program, IEI applied a highly automated smart-factory toolset—pick-to-light material handling, X-ray component counting, and automatic visual identification—to stabilize ramp. MES-linked traceability, AXI/vision inspection, and documented CAPA evidence further supported audit readiness.

Operating under its unified governance model—the IEI “Trust Stack”—IEI runs an ISO 13485/TFDA-compliant smart factory that spans ISO/IEC 27001 (information security), ISO 28000 (supply-chain security), IECQ QC 080000 (hazardous-substance process governance), and organization-level ISO 14064-1 GHG accounting. This framework reduces validation time, simplifies audits, and ensures end-to-end transparency for MedTech brands.

By aligning domestic TFDA compliance with global ISO frameworks, IEI provides medical customers with a transparent, audit-ready manufacturing base built for multi-market expansion.