IVD Product Clinical Trails and Usability Study
Medical Device Registration
Clinical Trail Consultancy
CLIA Lab Qualification Consultancy
Bio23 MedTech, Inc., founded by seasoned medical device experts, is headquartered in USA (Los Angeles, Houston) with offices in China (Shanghai, Suzhou, Guangzhou).
Our team brings extensive expertise in medical device development, production, clinical trials, and regulatory registration. We also specialize in access control, cleanroom construction, and equipment validation. With professional backgrounds in medicine, biology, pharmacy, and law, we are dedicated to supporting medical device manufacturers with global compliance certifications and overseas clinical trials.
About Us
— ABOUT US —
Overseas registration support regions
Overseas registration support regions
PhD Chief Scientist
CHIEF SCIENTIST
PhD in Biology from the Chinese Academy of Sciences(CAS)
Formerly affiliated with Baylor College of Medicine and University of Texas
Director of Operations
Certified Quality Management System Auditor
Senior Clinical Specialist in High-End Medical Devices
Successfully Led Numerous Cross-Border Clinical and Registration Projects
Zhu Hao
Co founder, CEO/COO
Our team
Hu Jinjie PhD
Chief Advisor
PhD in Comparative Pathology, University of California, Davis, postdoctoral fellow at NIH/NIAID in the United States with 12 years of FDA work experience, 10 years of senior consultant, proficient in FDA regulations and WHOPO requirements
Yuan Qiaoxia
Co founder, Vice General Manager, Registered Director
Regulatory Compliance Director
Specialist in medical device registration across 20+ countries
Extensive expertise in QMS implementation and factory on-site audits
倪振民
MD Ph.D. FACMG
首席专家顾问
在 CLIA 实验室运营和临床鉴定审查/调查方面经验丰富，长期担任 JCAHO 认证和年检、纽约州资质认证及年检、CAP 认证及年检、以及 CMS/CLIA 的认证及年检主持人。 过去17年，他领导 CLIA 临床分子诊断实验室及实验室自配试剂(LDT)开发，发表了许多临床和转化研究文章。同时在许多医学期刊担任编辑委员，为医学期刊与国际研究基金组织做专家审评。
Jinsong Zhang, PhD, HCLD(ABB)
FDA Clinical and Regulatory Experts
FDA Clinical and Regulatory Expert
Experience in CLIA laboratory supervision and deep knowledge of CLIA regulations
Formerly with the University of Texas Cancer Center and the Chinese Academy of Sciences
Outstanding achievements have been made in the research and work of infectious diseases, immunohematology, histopathology, and molecular pathology
Clinical Manager
Dr.Vassilis Tsilivakos MD PhD
Our cliients
Professional | Prudent | Responsible |Valuable
Global biological sample procurement
BIO23 overseas layout of biological sample library, with full process online and refined management to ensure the accuracy and availability of samples and related data. BIO23 is currently in contact with more resources to expand horizontally and vertically in synchronization with sample size and sample type.
