Empowering Medtech
to Go Global
End-to-end regulatory, clinical, and compliance solutions for medical device manufacturers and brands.
A Global Vision That Safeguards Every Market Entry
BIO23MedTech, Inc. is headquartered in Houston, Texas, and was founded by senior medical device industry experts. The team brings end-to-end experience across clinical medicine, product development, regulatory access and quality system certification. The company focuses on providing manufacturers with one-stop services spanning global compliance registration, authorized representation, quality system support and overseas clinical services for IVD products. With deeply collaborative hospital and laboratory networks across the US, Europe, China, Australia, Japan and Southeast Asia, we help clients enter global markets efficiently.
Three Core Capabilities
Local Regulatory Team
Our experts combine multi-market regulatory expertise with local knowledge and practical submission experience.
CLIA Lab & Global Collaboration Network
From specimen collection to analysis and reporting, BIO23 provides end-to-end support through our CLIA-certified lab and global partner network.
Standardized Execution That Shortens Timelines
SOP-driven workflows and coordinated project management help shorten timelines while maintaining compliance and quality.
A Global Business Footprint
In-country representative, Clinical Trails and QMS Support.
Coverage Across Key Medical Device Categories
Covering key device categories, from drug-device combinations and surgical robotics to IVD.
Measurable Results
From global reach to real-world delivery, BIO23 turns its capabilities into measurable results.
A Team with Deep Regulatory & Clinical Expertise
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.