Our Services
Product Design and Development
About
We deliver end-to-end product design and development services for medical devices, in vitro diagnostic instruments, and life sciences equipment—solving complex workflow automation challenges, accelerating innovation, and streamlining the path to commercialization.
Our multidisciplinary team—including systems, mechanical, electrical, test, manufacturing, firmware, and software engineers—collaborates closely with clients to develop innovative, 21 CFR Part 820-compliant solutions. By applying Agile methodologies within a robust regulatory framework, we rapidly iterate, prototype, and de-risk designs while ensuring full traceability, design verification, and process validation from concept to commercialization. This approach reduces development timelines and facilitates efficient regulatory approvals.
With deep expertise in fluidics, robotics, optics, smart sensors and image processing, precision motion control, thermal management, value engineering, embedded systems, and wireless technologies, we help transform our clients’ most complex workflows into compliant, scalable, market-ready products.
Case Study
Needle-Free Injector
Tool Handle Mechanism for Hemostatic Forceps: The OEM precision tool handle achieved CFDA certification via medical-grade polymer and robotic cleanroom automation.
Real-Time PCR Console
Real-Time PCR Console: The ODM real-time PCR console achieved CFDA/FDA certifications through modular thermal design and integrated logistics.
Tool Handle Mechanism for Hemostatic Forceps
Needle-Free Injector: The ODM/JDM hybrid project addressed pressure consistency (±5% variance), disposable design, and FDA/CFDA compliance.
