#Taiwan #New Taipei City #MedTech #IEI Integration #Certification

IEI Achieves Dual Certifications for MedTech

IEI Integration Corp., a leading global provider of medical and industrial computing platforms, has made significant strides in the medical technology sector by securing both the Taiwan Food and Drug Administration (TFDA) Quality Management System (QMS) approval and maintaining its ISO 13485 certification. This accomplishment, announced on November 21, 2025, underscores IEI's commitment to enhancing the standards of audit-ready manufacturing for medical device design transfers.

The Importance of Dual Certifications

The dual certifications serve as a cornerstone for manufacturers striving to navigate the complex landscape of medical device regulations. With these approvals, IEI can facilitate smoother design transfers and bolster regulatory compliance for its clients, particularly in the rapidly evolving sectors of OEM, ODM, and CDMO partnerships. The certification process ensures that the products manufactured meet stringent quality and safety standards, essential for gaining and sustaining trust in the healthcare industry.

Facilities and Production Capacity

Operating from its facilities in New Taipei City (Xizhi) and Qidu (Keelung), IEI can effectively support the burgeoning demand for medical technologies. The company is capable of producing 38,000 PCBA (Printed Circuit Board Assembly) units and 38,000 system units each month, thanks to its efficient production processes, offering its clients the flexibility to scale operations as needed. To further optimize manufacturing and logistics, additional capacity is in the planning stages in Taoyuan to meet the forecasted demand in the coming years.

Enhancing Compliance and Readiness

With its certifications, IEI provides a robust framework for its manufacturing processes. Kenny Jan, Senior Vice President of IEI's Medical Business Unit, emphasized that layering TFDA approval with ISO 13485 creates a more predictable audit environment, thereby expediting design transfers. This approach assists clients in introducing compliant products to clinical settings more quickly, which is paramount in a sector where timing can significantly impact patient care.

Technical Innovations in Manufacturing

IEI has also invested in automation technologies to enhance its manufacturing capabilities. For instance, in the production of a Class II endoscopic device, the use of smart factory tools, such as pick-to-light material handling systems and X-ray component counting, ensures accurate assembly and minimizes errors. Additionally, the implementation of a traceability system linked with Manufacturing Execution Systems (MES) further enhances quality assurance and regulatory compliance by providing real-time data on production processes.

Commitment to Quality and Security

The foundation of IEI’s manufacturing excellence lies in its governance framework, known as the “Trust Stack.” This unified model encompasses multiple standards, including ISO 27001 for information security, ISO 28000 for supply chain security, ISO 14064-1 for greenhouse gas accounting, and IECQ QC 080000 for hazardous substances. By adhering to these comprehensive standards, IEI ensures transparency and accountability throughout its operations, which is vital for maintaining certification and market confidence.

Future Outlook

As IEI aligns its domestic compliance with international frameworks, it positions itself as a critical player in the global med-tech ecosystem, ready to cater to diverse market needs. The focus on maintaining high manufacturing standards while expanding operational capacity underscores IEI's strategic vision for growth in the MedTech landscape.

In conclusion, IEI Integration Corp.’s recent achievements not only highlight its dedication to manufacturing excellence and regulatory compliance but also reinforce its ability to respond effectively to the evolving demands of the healthcare industry globally. Companies seeking to navigate the complexities of medical device production can look to IEI as a trusted partner equipped with the necessary certifications and expertise. For more information, you can visit the IEI Medical Portal.