About Us

Center Overview

The AI Certification and Validation Center of the Far Eastern Memorial Hospital Alliance (FEMH-CCVAI) is one of the “Clinical AI Certification and Validation Centers” promoted by Taiwan’s Ministry of Health and Welfare. Established under the guidance of the national Smart Healthcare Three Major AI Centers Program, FEMH-CVVAI specializes in supporting the clinical validation and TFDA certification of medical AI products.
As a cross-hospital platform dedicated to advancing the certification and validation of medical AI products, our center focuses on helping vendors obtain TFDA certification and accelerating the clinical implementation and adoption of medical AI technologies. Beyond being a support organization for validation and certification, we also serve as a collaborative partner in AI technology development. Leveraging extensive experience and professional services, we provide comprehensive support to vendors—from conceptual development to clinical application.
Our center is composed of Far Eastern Memorial Hospital in collaboration with Taipei Veterans General Hospital, Shuang Ho Hospital, E-Da Hospital, Taitung Mackay Memorial Hospital, and several other institutions. Through multi-hospital horizontal cooperation, we offer efficient, one-stop multicenter clinical validation solutions. This structure not only enhances the efficiency of validation but also ensures that AI technologies are applicable across diverse scenarios and environments.
Additionally, we proactively assist vendors in communicating with the Taiwan Food and Drug Administration (TFDA), offering services in technical documentation preparation, regulatory consultation, and validation design. Our aim is to help smart medical device manufacturers achieve TFDA certification with the smoothest process possible.
Our services further extend to the development and optimization of AI technologies. We provide interdisciplinary professional support, assisting vendors with AI model design and training, data annotation and management, as well as clinical testing and optimization of their products. This ensures that AI technologies can be rapidly commercialized and deliver maximum value in clinical practice.

Mission & Vision

Mission:

To provide efficient and professional AI certification and verification services, helping the industry shorten product time-to-market, drive medical innovation, and support AI technology development and application, injecting new momentum into the healthcare sector.

Vision:

To become Asia’s leading AI medical technology certification center, enhancing Taiwan’s global competitiveness and influence in the medical technology field. We aim to establish an AI development ecosystem built on industry-academia-medical collaboration as its foundation.

Description of the Center’s Work
Assisting AI Products with Clinical Validation:

The center helps vendors design and execute multicenter clinical trials to ensure the effectiveness and safety of AI models across different healthcare settings.

Providing Regulatory and Technical Consultation:

The center offers services such as the preparation of technical documents required for TFDA certification, regulatory consultation, and validation design, supporting vendors in obtaining certification smoothly.

Promoting Clinical Application of AI Technologies:

The center collaborates with physicians to integrate AI technologies into clinical workflows, enhancing diagnostic efficiency and accuracy, and ultimately improving the quality of patient care.

Team Introduction

Our team consists of experts from Far Eastern Memorial Hospital (FEMH) and our partner hospitals within the alliance.

FEMH Experts: Our specialists have extensive clinical experience, verification expertise, and regulatory knowledge. The team includes clinical physicians, data annotation specialists, regulatory specialists, AI engineers, and professional project managers, ensuring a comprehensive approach to AI certification and verification.

Partner Hospital Experts: Our allied experts include medical device regulatory specialists, human clinical trial experts, and principal investigators from various medical fields, contributing to a well-rounded and multidisciplinary verification process.

Our team is committed to delivering high-quality, efficient verification services while actively collaborating with industry and academia to advance AI technology development and clinical implementation.

Partners

Our collaboration network includes the Ministry of Health and Welfare (MOHW), domestic and international AI medical technology companies, industry-academia collaboration institutions, and multinational healthcare technology corporations.

Through these partnerships, we integrate resources to support the entire AI technology journey—from laboratory research to clinical application, fostering the rapid advancement of innovative medical technologies.

Our goal is not only to assist manufacturers in completing certification but also to serve as a strategic partner in AI development, working together to shape the future of smart healthcare.

Our Partners

AI Development Center of Taipei Veterans General Hospital

AI Medical Research Center of Taipei Medical University

Smart Healthcare Center of E-Da Hospital

Mackay Memorial Hospital – Taitung Branch