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About CIBDS Lab

  This laboratory is a team of Professor You-Yin Chen from the department Biomedical Engineering of National Yang-Ming University. This laboratory has been established for 17 years since 2004. CIBDS Lab uses biomedical electronics, physiological signal analysis, medical information system and artificial intelligence (AI) theory applied to cross-domain technical research and development, willing to solve or improve the problems encountered in the clinic, and cooperate with the verification of human experiments. CIBDS Lab has a number of core technologies, including wearable smart medical device design / analysis / manufacturing, human-computer interaction calculations, smart medical algorithm development and design, smart medical regulations testing, and medical information system platform construction. Considering the rigor of medical devices, CIBDS Lab establishes standards for testing of medical electrical products and quality management system planning and internationally recognized by  Taiwan Accreditation Foundation (TAF). 

  CIBDS Lab has collaborated with many hospitals on research projects. It has also assisted manufacturers in solving industry problems by means of industry-academia cooperation and all have achieved good results. In terms of instrumentation equipment, this laboratory includes:

1. Wearable device tester: Multifunctional comprehensive performance tester, compatible with ECG and reflective PPG optical heart rate wearable device, which can simultaneously output ECG and PPG analog signals, and even integrate ECG and PWTT pulse wave transit time between PPG signals.
We also comply with the latest international medical standards at the same time:
(1) Refer to IEC 60601-2-47:2012 Single-lead ECG safety and functional test related standards.
(2) Refer to ISO 80601-2-61:2017 Transmittance or reflective light volume change tracing chart safety and functional test.
(3) Refer to IEC 80601-2-30:2018 Wearable noninvasive blood pressure measurement system functional test.
(4) Human database and free moving situation test (ex: Exercise test on the treadmill): Multimodality human database testing with the simulated free moving situation for safety and performance verification.
(4) ISO 62304: 2015 Medical device software-Software life cycle processes with FDA Software Guidances.
(5) ISO 14971: 2019 Medical devices — Application of risk management to medical devices and consulting service.
2. Artificial Intelligence / Mahcine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Software Validation:
(1) Safety and performance verification Platform in Artificial Intelligence Medical Assistant Diagnosis System.
(2)AI adversarial machine learning test.