Certification and Verification Commission Application

Service Flow 1: Document Processing Procedures

Consultation stage: Provide initial assessment of product verification, discuss by phone or meeting.
Acceptance of commission: The client provides a draft of the clinical trial plan and prepares relevant documents. The certification and verification center will discuss and confirm the verification details with the client.
Inquiry to TFDA: The certification and verification center will assist the manufacturer in preparing technical documents that comply with TFDA regulations and inquire about TFDA registration.
Signing of contract: Confirm the responsibilities, cooperating hospitals, and rights and obligations of the commissioning manufacturer, and sign a contract. [Download contract example]
IRB review: Assist the manufacturer in completing the IRB application and review for the main responsibility and cooperating hospitals.

Confirmation of AI product: Evaluate the training data, model training method, and confirm whether the product derives risks.
Preparation of test data: Retrieve images and medical records, download images, and label gold standard answers.
Execution of verification: Deploy the manufacturer's AI model on a federal learning server, or provide an AI system to the hospital, or have the certification and verification center staff bring the test data set to the manufacturer's AI machine for testing. Conduct functional, performance, and safety tests of the AI product.
Verification analysis and performance evaluation: Analyze according to the main and secondary purposes of the product description, and analyze subgroups as necessary. Consider risk management and safety testing for sensitive topics.
Provide feedback and data assistance: Provide professional feedback on use and verification. If necessary, provide alliance data sets to improve the AI product.

Manufacturers developing AI medical image or text technology or clinical decision support systems.
Fees vary depending on the number of verification hospitals, retrieval, images, and labeling quantity. Details will be discussed in person.