All-in-One Contract R&D and Certification Test Services for Medial AI Device

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委託研究開發(CDMO)、檢測驗證(TAF Lab)、臨床試驗規劃與執行(CRO)

We offer various testing services to guarantee your medical device for healthcare applications.

Wearable Electrocardiogram (ECG) Smart Device Safety and Functional Test

Wearable Photoplethysmogram (PPG) Smart Device Safety and Functional Test

Hearing aid (HA)/OTC HA Functional Test

Wearable Medical Device Software Validation and Risk Assessment

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Other services for you

智慧醫療法規認證 / 客製設計檢測

Smart Medical Regulation Certification / Custom Design Testing

•U.S. Food and Drug Administration •International Electrotechnical Commission •International Organization for Standardization •Taiwan Food and Drug Administration •CE Marking (CE Mark)

生醫訊號演算法模組 (演算庫)

Biomedical signal AI/ML-based algorithm module (Algorithm library)

•Resting Heart Rate •Dynamic Heart Rate •Atrial Fibrillation •Blood Pressure •Heart Rate Variability •Blood Oxygen Saturation ......

穿戴式醫療器材 / 實驗製具開發設計

Development and design of wearable medical equipment / experimental tools

•Hardware reference design •Firmware implementation •Real-time wearable system developemnt •BLE wireless communication interface •App referecnce design ......

醫學資訊系統平台架設 (聯邦健康保險法案相容)

Hospital Information System (HIS) development (HIPAA Compliant)

•Hospital Information System •Firewall for HIPAA Web Hosting Compliance •HIPAA-Compliant Encrypted VPN •HIPAA-Compliant Offsite Backups •SSL certificates for HIPAA Compliance

CIBDS Lab offers wearable devices validation report for more advanced AI healthcare applications.

Dr. Kang

PMR Director @ TMUH
Quality of clinical data from wearable devices can be proved by CIBDS Lab that I can use in my sleep analysis study safely.

Dr. Lin

Neurology Director @ HTCH
CIBDS Lab offers various testing services to guarantee your wearable device for healthcare application.

Dr. Lui

Neurology Director @ TCH
CIBDS Lab guarantees the efficiency of a wearable device that I can provide significant prevention information for remote medical care.

Dr. Hsu

Cardiologist @ TVGH
I should be so lucky that I almost don't worry about the problem of my wearable devices for clinical studies after I meet the CIBDS Lab.

Dr. Lo

Assistant Professor @ TMU