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

