Grai Orthopedic Implants
Grai Orthopedic Implants
ISO 13485 Certified · FDA Cleared · CE & MDR Compliant · 15,000 m² State-of-the-Art Facility · 500+ Professionals Dedicated to Your Success
GRAI Medical is a leading professional medical device manufacturer operating from a 15,000 m² state-of-the-art facility. Our factory is certified with ISO 13485 and BSCI, and our products carry internationally recognized CE, MDR, and FDA certifications — ensuring the highest standards of safety, quality, and compliance in every product we deliver.
With a dedicated workforce of 500 employees — including 8 senior engineers and 10 specialized quality control professionals — we combine deep engineering expertise with rigorous quality assurance to serve healthcare providers and distributors worldwide.
Our commitment goes beyond manufacturing. We are a trusted long-term partner for hospitals, distributors, and healthcare brands seeking reliable, innovative, and fully compliant medical devices with comprehensive OEM/ODM capabilities.
Our certifications demonstrate our unwavering commitment to international quality, safety, and regulatory standards across all product categories.
What sets GRAI Medical apart from other medical device manufacturers in quality, innovation, and service.
Our in-house laboratory is equipped with cutting-edge instruments for comprehensive product testing, ensuring every device meets or exceeds international safety and performance benchmarks before shipment.
A dedicated team of 10 QC specialists implements multi-stage inspection protocols — from incoming raw materials through semi-finished components to final packaged products — guaranteeing zero-defect delivery.
Every raw material is tagged with full traceability identification, allowing us to track the complete lifecycle of each component — a critical requirement for medical device compliance and post-market surveillance.
From minor product modifications to full OEM/ODM development, our engineering team can adapt specifications, materials, dimensions, and packaging to precisely match your brand and market requirements.
With 15,000 m² of manufacturing space and 500+ employees, we have the infrastructure to handle both small MOQ orders and large-volume production runs with consistent quality and on-time delivery.
Our regulatory affairs team has deep experience in CE, MDR, FDA, and other international certifications, providing clients with full documentation support for market entry in Europe, the US, and beyond.
Our experienced research and development team continuously drives product innovation, keeping your portfolio competitive and ahead of market trends.
Over 300 different medical device models currently available across multiple clinical categories, giving distributors and healthcare providers a comprehensive one-stop sourcing solution.
Our R&D team introduces a minimum of 10 new products every month, reflecting our commitment to continuous innovation and responsiveness to evolving clinical needs and regulatory requirements.
Every product can be tailored — from clinical specifications and materials to branding, labeling, and packaging design — ensuring your private label or OEM product stands out in your target market.
GRAI Medical is your ideal OEM partner — from concept development to regulatory approval and mass production, we handle every step with precision and expertise.
| OEM Service | Details & Capabilities |
|---|---|
| Product Customization | Minor Modifications Full ODM Development Material Selection Dimension Adjustment |
| Branding & Packaging | Private Label Custom Logo Custom Packaging Design Multi-language IFU |
| Regulatory Support | CE / MDR Documentation FDA 510(k) Support Technical File Preparation Agency Policy Assistance |
| Quality Assurance | ISO 13485 QMS Raw Material Traceability In-process Inspection Final Product Testing |
| Production Capacity | Small MOQ Available Large Volume Production 15,000 m² Facility 500+ Workforce |
| After-Sales Service | 1-Year Free Replacement Dedicated Account Manager Technical Support Agency Policy Assistance |
A rigorous, multi-stage quality control framework ensures every product leaving our facility is safe, effective, and fully compliant.
All incoming raw materials are inspected and assigned full traceability identification codes. Only materials meeting our strict specifications are approved for production use.
Semi-finished products undergo systematic inspection at critical production stages. Our QC team monitors dimensions, materials, and assembly quality in real time.
Advanced laboratory facilities conduct comprehensive performance, safety, and biocompatibility testing to verify compliance with CE, MDR, and FDA requirements.
Every finished product batch undergoes final inspection and sampling tests before packaging and shipment, ensuring zero-defect delivery to our global partners.
A selection of successful OEM and supply partnerships demonstrating our expertise across diverse medical device categories and global markets.
Developed a complete private-label product line for a leading European medical distributor, including full CE/MDR documentation, custom packaging in 6 languages, and ongoing supply of 15+ SKUs with consistent 12-week lead times.
Supported a US healthcare brand through the full FDA 510(k) submission process, including technical file preparation, biocompatibility testing, and clinical data compilation, resulting in successful market clearance within 14 months.
Established a long-term supply agreement with a major Middle Eastern hospital group, delivering 300+ product models with full traceability documentation, meeting strict procurement compliance requirements across 8 facilities.
Trusted by distributors, healthcare brands, and hospital procurement teams across Europe, North America, and Asia.
"GRAI Medical has been our OEM partner for over 3 years. Their ISO 13485 quality system and raw material traceability give us complete confidence in every shipment. The CE and MDR documentation support has been invaluable for our EU market operations."
"The R&D team at GRAI Medical is exceptional. They introduced custom product modifications within 3 weeks and handled all FDA documentation professionally. Their 1-year free replacement policy reflects genuine confidence in their product quality."
"We source over 200 SKUs from GRAI Medical for our hospital network. Their quality control process — from raw material traceability to final product inspection — gives our clinical teams complete peace of mind. Highly recommended as a trusted medical device supplier."
Eight compelling reasons why healthcare brands, distributors, and hospital procurement teams choose GRAI Medical as their long-term manufacturing partner.
CE, MDR, and FDA — covering the world's most demanding regulatory markets simultaneously.
Advanced laboratory facilities for comprehensive product testing without reliance on third-party labs.
Immediate access to over 300 certified medical device models — fastest time-to-market for distributors.
From minor customization to full product development — complete private label and branding support.
Our commitment to you extends well beyond delivery. We provide comprehensive after-sales support to protect your business and ensure long-term partnership success.
We stand fully behind every product we manufacture. Any product found to have quality defects within one year of delivery will be replaced free of charge — no questions asked. This guarantee reflects our confidence in our manufacturing quality and our commitment to your business continuity.
Our experienced regulatory and after-sales team provides comprehensive agency policy assistance, helping you navigate distributor agreements, regulatory compliance requirements, and market authorization processes in your target countries. We are your partner in every market you serve.
Every client is assigned a dedicated account manager who provides responsive communication, order tracking, technical support, and proactive problem resolution — ensuring a seamless, professional experience from first inquiry to long-term partnership.
Join hundreds of healthcare distributors and brands worldwide who trust GRAI Medical for reliable, certified, and innovative medical device manufacturing.
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