Innovation Engineered for Scalable Commercialization
FIH Health & Biotech is a premier provider of contract design, development, and manufacturing services for OEMs in the medical device, in vitro diagnostics (IVD), and life sciences industries. With over 30 years of experience, we accelerate the Product Realization Process from concept to full-scale production, ensuring rapid time-to-market without sacrificing quality or regulatory compliance.
Global Network
Our global network of FDA 21 CFR Part 820-compliant and ISO 13485-certified facilities–located in San Diego, CA; Dallas, TX; Chihuahua, Mexico; Taipei, Taiwan; Tu Son, Vietnam; and Beijing, China–provides a seamless commercialization ecosystem, minimizing complexity, cost, and regulatory risk for Medtech OEMs.
USA
San Diego, CA
USA
Dallas, TX
Vietnam
Tuson
Taiwan
Taipei
Mexico
Chihuahua
China
Langfang (Beijing)
Our Capabilities
Product Design and Development
Expertise in fluidics, robotics, optics, smart sensors, image processing, precision motion control, thermal management, value engineering, embedded controllers, and wireless systems. Leveraging Agile methodologies, we ensure risk mitigation, traceability, and full regulatory compliance.
Contract Manufacturing
Comprehensive manufacturing solutions, including PCB assembly (PCBA), precision machining, tooling and injection molding, electromechanical and fluidic system integration, testing, quality control, and process validation including automated reagent filling and packaging for scalable production.
Global Supply Chain and After Market Services
As part of the Foxconn family, we leverage the world’s largest and most sophisticated supplier network to ensure unmatched supply continuity, cost efficiency, and regulatory compliance. Our 21 CFR Part 820 / ISO 13485-compliant aftermarket services include repair, refurbishment, spares & FRUs management, and forward/reverse logistics.
Quality and Regulatory Compliance
We ensure full compliance with global industry standards, including ISO 13485, ISO 14971, IEC 60601, IEC 60529, IEC 62304, ISO 9001, ISO 14001, ISO 45001, IATF 16949, and CTPAT. Our robust quality management system integrates SPC, IQ/OQ/PQ validation, and continuous process monitoring to ensure compliance, traceability, and audit readiness.
Why Partner with FIH Health & Biotech?
Deep Industry Specialization
Genomics, Sequencing & Multi-Omics Technologies
Sample Preparation & Lab Automation
In Vitro Diagnostics (IVD) & Pathology
Synthetic Biology & Bioengineering
Cell and Gene Therapy and Biomanufacturing
Minimally Invasive Surgery Devices & Surgical Robotic Systems
Neuromodulation and Nerve Stimulation Technologies
Diabetes and Digital Health Solutions
Diagnostic Imaging and AI Powered Radiology
Drug Delivery & Wearable Devices
Custom-Centric Approach
Collaborate with a partner committed to understanding your unique requirements at every stage of the product development process. Together, we’ll accelerate innovation and drive successful commercialization
Global Scale
Leverage our global footprint to access cost-optimized design, development, and manufacturing solutions. Whether onshore, nearshore, or offshore (Southeast Asia and China-for-China), we deliver scalable, compliant manufacturing and supply chain solutions, ensuring faster time-to-market and reliable production for complex medical, life sciences, and biotech innovations.
Sustainability Commitment
Stay aligned with your sustainability goals with ease. As an ISO 14001-certified company, we integrate sustainable practices across all our operations, helping minimize environmental impact while ensuring compliance with global standards.
Innovation to Commercialization
Partner with FIH Health & Biotech to transform your groundbreaking medical, life sciences, or biotech innovation into reality.