Grai Orthopedic Implants
Grai Orthopedic Implants
In the rapidly evolving landscape of medical technology, Total Hip Replacement (THR) manufacturing requires a synthesis of materials science, precision engineering, and rigorous regulatory adherence. As a leading OEM/ODM partner, we recognize that hip arthroplasty is not just a procedure; it is a restoration of quality of life for millions globally.
Our commitment to innovation is reflected in our 15,000 m² facility. We focus on:
Leveraging the robust manufacturing ecosystem in China, we provide unmatched efficiency without compromising quality. Our ISO 13485 and BSCI certifications, combined with MDR/FDA compliance, ensure that our supply chain is resilient against global disruptions. We maintain full traceability of raw materials—a critical differentiator in the orthopedic sector.
We understand the complexities of international medical device regulations. Our dedicated R&D team and senior engineers facilitate minor customization and rapid prototyping, ensuring that your specific market needs—whether in the EU, US, or emerging markets—are met with precision. From 10 new product introductions per month to comprehensive QC processes, we are an extension of your brand.
Utilizing wire-electrode cutting and high-speed CNC for exact tolerances.
Every batch undergoes semi-product and finished product inspections.
In-house testing for mechanical strength and material purity.
CE and FDA compliant supply chain processes for global export.
Q: What is your typical turnaround time for new OEM hip implant designs?
A: With our 8 senior engineers and rapid prototyping capabilities, we introduce 10 new products monthly. Customization timelines depend on complexity but generally follow a streamlined agile workflow.
Q: How do you guarantee traceability in your supply chain?
A: We enforce strict raw material traceability identification, ensuring every component can be tracked back to its batch and material source, complying with ISO 13485 standards.
Q: Do you provide support for regulatory submissions?
A: Yes, we provide necessary technical documentation and support for CE, MDR, and FDA submissions to assist our partners in clearing regulatory hurdles.
