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IEI Secures TFDA QMS Approval and ISO 13485 Certification, Reinforcing Audit-Ready Manufacturing for MedTech Design Transfers
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.
, 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." said , Senior Vice President of IEI's Medical Business Unit.
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 ���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.
Founded in 1997, IEI Integration Corp. is a global provider of medical and industrial computing platforms and CDMO/ODM services. IEI enables regulated MedTech and edge-AI applications through design-to-manufacturing expertise, delivering advanced medical computers, network appliances, and embedded platforms supported by robust quality, regulatory, and cybersecurity frameworks.
For more MedTech information, visit the .
Learn more about IEI at .
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