ISO 13485:2016
Certified Quality Management System specific to medical device manufacturing, component processing, and clean assembly.
Rigorous Quality Assurance
Quality That Meets Global Industry Standards — And Yours
Greyack medical Co., Ltd operates under validated quality management systems tailored for high-precision contract manufacturing. We empower international OEM partners to accelerate market launch while adhering to strict FDA and ISO regulatory frameworks.
FDA Registered
Establishment registration with the U.S. FDA, maintaining complete compliance for class I, II, and III device components.
ISO 9001:2015
Standardized corporate quality infrastructure supporting continuous improvement, risk control, and operational efficiency.
AS9100D Certified
Aerospace-level precision standards applied to critical surgical robotics and high-tolerance implant applications.
Audit-Ready Manufacturing
Uncompromised Traceability & Risk Management
For medical OEMs qualifying international supply chains, documentation integrity is as critical as micro-inch dimensional accuracy. At Greyack medical Co., Ltd, every production batch is backed by full raw material certs, in-process inspection data, and validated cleaning or passivation protocols.
Our quality engineering team actively assists procurement and regulatory leaders during supplier qualification audits, first article inspection approvals (FAI), and technical submission documentation.
Full Material Traceability & Melt Certificates
Complete heat lot traceability on medical titanium, cobalt-chrome, PEEK, and stainless steel alloys.
First Article Inspection (FAI) Reports
AS9102 / ISO compliant full dimensional inspection data utilizing multi-sensor CMM and optical laser measuring.
Validated Process Control (IQ / OQ / PQ)
Strict validation across CNC precision machining, laser marking, ultrasonic cleaning, and passivation.
Operational Standards
Facility Certifications & Registration Directory
Review the specific quality accreditation records maintained across our specialized manufacturing facilities.
| Manufacturing Division | Core Capabilities | Regulatory Credentials | Quality Standards |
|---|---|---|---|
| Greyack Medical — Implants & Spine Division | Precision CNC Machining, Swiss Turning, Bone Screw Threading | FDA Registered | ISO 13485:2016 Certified |
| Greyack Medical — Surgical Instruments & Grinding | Medical Flute & Drill Grinding, Custom Instruments, Finishing | FDA Registered | ISO 13485:2016 Certified |
| Greyack Medical — MedTorque Division | Silicone Handles, Torque-Limiting Drivers, Ratcheting Tools | FDA Registered | ISO 13485:2016 Certified |
| Greyack Medical — Additive Manufacturing Facility | Direct Metal Laser Sintering (DMLS), Porous Implant Structures | FDA Registered | ISO 13485:2016 Certified |
| Greyack Medical — Aerospace & Robotics Components | Surgical Robotics End Effectors, High-Complexity Micro Machining | FDA Registered | ISO 13485:2016 / AS9100D Certified |
Need Certification Documentation or Supplier Audit Info?
Contact our quality engineering team directly at: [email protected]