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Capabilities • End-to-End Support

End-to-End Medical Contract Manufacturing Support

FDA Registered Establishment
ISO 13485 Certified Quality System
Global Medical Device OEM Supply Integration

At Greyack medical Co., Ltd, we offer medical OEMs a comprehensive, scalable range of engineering resources, production capacity, finishing capabilities, and supply chain integration. Under one ISO 13485-certified quality management umbrella, we simplify supplier qualification, ensure stringent process validation, and accelerate time-to-market for critical implants, surgical instruments, and robotic sub-assemblies.

Integrated Disciplines

Comprehensive Capabilities from Prototype to Serial Production

Our unified contract manufacturing model eliminates multi-vendor handoffs, reduces lead times, and maintains total component traceability from raw material to sterile-ready delivery.

Engineering & Design Assist

Our experienced application engineers collaborate directly with OEM engineering teams during early-stage development. We optimize design-for-manufacturability (DFMA), refine tight-tolerance geometries, and help select cost-effective production routes without compromising functionality.

Focus: DFM, CAD/CAM optimization, cost reduction

Materials Expertise

Decades of specialized processing experience in medical-grade materials. We machine, grind, and print implantable titanium alloys (Ti-6Al-4V ELI), cobalt-chrome (CoCrMo), medical stainless steel grades (17-4PH, 316L, 455), nitinol, and high-performance polymers including PEEK and Radel.

Materials: Titanium, CoCr, Stainless, PEEK, Nitinol

Additive Manufacturing

Utilizing state-of-the-art powder-bed fusion (PBF) technology on top-tier direct metal laser sintering equipment, we produce highly complex porous structures for bone ingrowth implants, custom surgical guides, and lightweight robotic end-effectors with minimal material waste.

Tech: Direct Metal Laser Sintering (DMLS), Porous Lattices

Precision CNC Machining

Equipped with multi-axis Swiss-turning lathes, 5-axis CNC machining centers, and automated high-speed cells, Greyack medical Co., Ltd holds micron-level tolerances across complex orthopedic bone screws, spinal plates, dental abutments, and robotic components.

Tolerances: Micron-level accuracy, 5-Axis Milling, Swiss Turning

Medical Grinding

Specialized flute, drill-point, profile, and thread grinding capabilities for surgical cutting tools. We manufacture drills, taps, reamers, burs, and guide wires engineered to maintain sharp cutting edges and deliver flawless surgical performance.

Tools: Surgical drills, taps, reamers, burs, guide pins

Finishing & Assembly

Complete post-processing services, including ultrasonic cleaning, citric/nitric passivation, bead blasting, anodizing, electropolishing, laser marking, and cleanroom mechanical sub-assembly. We turn precision parts into ready-to-use finished products.

Services: Passivation, laser marking, electropolishing, assembly

Quality Assurance

Operating strictly under ISO 13485 standards, our quality teams execute full IQ/OQ/PQ process validations, First Article Inspections (FAI), automated coordinate measuring machine (CMM) reports, and 100% optical laser metrology for critical dimensions.

Compliance: ISO 13485, FDA registered, CMM reports, FAI

Transition Sourcing

Mitigate transfer risk when moving production from incumbent suppliers or internal facilities. Our structured transfer protocol ensures seamless tooling migration, drawing verification, process re-validation, and zero delivery interruption for your product lines.

Risk Control: Tooling transfer, rapid qualification, seamless handover

Supply Chain Integration

Streamline procurement with our value-added supply chain management options. We offer Vendor-Managed Inventory (VMI), kanban stocking, customized kitting, pouch packaging, and global logistics coordination to minimize stockouts and improve cash flow.

Logistics: VMI programs, customized kitting, pouch packaging
Why Sourcing Leaders Choose Greyack

Single-Source Responsibility for Global Medical Device OEMs

In the medical device industry, fragmented supply chains lead to increased regulatory risk, cumulative tolerance stack-ups, and delayed launch timelines. Greyack medical Co., Ltd operates as a true strategic partner, unifying every manufacturing stage under a rigorous FDA-registered quality system.

  • ISO 13485 certified quality management with comprehensive lot traceability
  • Dedicated engineering teams for rapid design-for-manufacturability feedback
  • Advanced multi-axis CNC Swiss machining, grinding, and metal 3D printing
  • Integrated surface finishing, cleanroom assembly, and sterile-ready packaging

Elevate Your Production Standards

Whether you need rapid prototyping for upcoming clinical trials, high-volume production for established orthopedic lines, or risk-managed vendor consolidation, Greyack medical Co., Ltd has the technical infrastructure and capacity to support your goals.

Our technical team reviews drawings, CAD files, and quality specifications to deliver actionable engineering feedback and competitive quotes for international buyers.

Frequently Asked Questions

OEM Sourcing & Capability Guidance

What is included in Greyack Medical's end-to-end support?

Greyack medical Co., Ltd offers seamless support across the full product lifecycle: design for manufacturability (DFM) guidance, raw material sourcing, prototype development, CNC precision machining, additive manufacturing, medical grinding, surface finishing, cleanroom sub-assembly, and inventory management.

How does Greyack Medical ensure quality and regulatory compliance for international OEMs?

Our facility operates under an ISO 13485-certified Quality Management System and FDA establishment registration. Every component undergoes rigorous CMM inspection, laser metrology, validation (IQ/OQ/PQ), and full material lot traceability to support customer DHF and regulatory filings.

Can Greyack Medical assist with vendor consolidation and transition sourcing?

Yes. We specialize in transition sourcing for OEMs looking to consolidate their supplier base. Our technical team manages risk transfer, process re-validation, tooling migration, and initial sample inspection (FAI) to ensure uninterrupted production.

What medical grade materials do you regularly process?

We work extensively with titanium alloys (Grade 5, Ti-6Al-4V ELI), cobalt-chrome alloys, medical-grade stainless steels (17-4PH, 316L, 455, 465), nitinol, and engineered polymers such as PEEK, Radel, and Ultem.

Discuss Your Precision Manufacturing Requirements

Connect with our technical engineering team directly: [email protected]

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