Procurement FAQ
Frequently Asked Questions by Global Medical Buyers
Expert answers addressing regulatory compliance, material testing, ordering logistics, and custom OEM manufacturing options.
Q
What medical-grade raw materials are utilized in your external fixators and retractor sets?
We exclusively manufacture using certified implant-grade materials including AISI 316L (1.4441) Stainless Steel, Titanium Alloy Ti-6Al-4V ELI (ASTM F136), Aerospace-grade 7075-T6 Aluminum Alloy (hard-anodized for pin clamps), and high-tensile Carbon Fiber composites for radiolucent connecting rods. Material test certificates (MTC) according to EN 10204 3.1 are supplied with every order shipment.
Q
Do your external fixation systems hold international regulatory approvals (CE, ISO, FDA)?
Yes. Our facility is certified under ISO 13485:2016 and ISO 9001:2015. All external fixation frames, bone pins, Schanz screws, and surgical retractor instrument kits comply with the EU Medical Device Regulation (MDR 2017/745) Class I / Class IIb requirements and bear the CE mark. Technical documentation (STED) and Declaration of Conformity (DoC) are available for international registration.
Q
What is your Minimum Order Quantity (MOQ) for custom OEM and private labeling?
For standard catalog items, we maintain inventory with flexible MOQs starting from 10 sets. For custom OEM manufacturing, laser-etching your brand logo, customized surface treatments (DLC/HA coatings), or specialized tray layouts, our baseline MOQ starts at 300 units per specification.
Q
How do you guarantee mechanical stability and fatigue resistance under cyclic load testing?
Every batch of fixators undergoes static bending, torsional stiffness, and dynamic axial fatigue testing in accordance with ASTM F1541 (Standard Specification and Test Methods for External Skeletal Fixation Devices). Our internal quality control lab evaluates pin-clamp slip torque resistance under maximum weight-bearing scenarios before lot release.
Q
Can your factory produce radiolucent carbon fiber external fixator rods?
Yes. We produce carbon-fiber reinforced polymer (CFRP) rods in diameters ranging from 4.0mm (small fragment) to 11.0mm (large fragment trauma systems). These rods offer complete radiolucency under fluoroscopy without artifact disruption, allowing clear fracture line visualization.
Q
What is the standard production lead time and global export delivery schedule?
Standard inventory items ship within 3–5 working days upon order confirmation. Custom OEM production runs typically require 15–25 business days depending on geometric complexity and surface coating requirements. We support door-to-door air freight (DHL, FedEx, UPS) and containerized sea freight to over 50 export countries.
