Company Introduction
BIO23 MedTech, Inc. was co-founded by medical device industry experts with backgrounds in clinical research, manufacturing, regulatory science, medicine, law, and biology. Our team brings hands-on experience from leading global CROs, medical device manufacturers, and regulatory agencies, with expertise across the full lifecycle of medical device compliance.
Headquartered in Houston, Texas, BIO23 operates wholly owned offices in China (Shanghai, Suzhou, and Guangzhou), Hong Kong, Vietnam, Malaysia, and Indonesia. Our global network supports clients across major markets in Asia and North America.
BIO23 provides four core service areas for medical device manufacturers and brand owners: International Clinical Trials, Global Registration, Biobank Services, and QMS Compliance. We help clients achieve global market access through specialized, efficient, and localized services.
Core Team
Our team brings together experts from the US, Europe, and Asia, with multi-market regulatory certifications and an average of 15+ years of industry experience.
Leads diagnostic platform and assay development, focused on translating frontier diagnostic technologies into practice.
Deep expertise in FDA clinical and regulatory affairs, with a strong grasp of multi-market submission pathways.
Provides strategic and compliance counsel, connecting international resources with local execution.
Oversees registration operations and review systems to ensure efficient, compliant delivery.
Leads international multi-center clinical study design and execution across the US, Europe and Asia-Pacific.
Specializes in overseas market access and registration strategy across emerging markets.
Global Offices
US Headquarters with Offices Across China & Southeast Asia
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