Product details of the medical device component manufacturers
Quick Overview
In order to provide the best quality medical device component manufacturers, KGL never skimps on raw materials. With superior craftsmanship, KGL ensures the quality of this product. This product is offered in various, patterns, colors, sizes and finishes as per the variegated demands of our valuable clients.
Product Information
Compared with other similar products in the market, KGL's medical device component manufacturers is provided with the following outstanding advantages.
| Material |
Aluminum, Nylon, Steel, Plastic, Brass, Alloy, Copper, Aluminum, Iron(optional) |
Production |
TBD by volume |
| Process |
5-Axis CNC Simultaneous Machining + EDM |
Working Temp |
Up to 18℃ ~ 25℃ continuous service |
| Tolerance |
±0.005mm (blade profile), ±0.003mm (bore) |
Certification |
AS9100D / ISO 9001: 2015 / ISO 13485:2016 |
| Surface Finish |
Ra ≤ 0.8μm (flow path), Ra ≤ 0.4μm (seal faces) |
Inspection |
HEXAGON CMM + KEYENCE 3D Microscope + Full FAI |
| Max Diameter |
Up to Ø40–60 mm/ Ø60–100 mm |
Lead Time |
Prototype: 15–25 days |
The advantages of the product
The curved design conforms to ergonomic principles, the metal construction offers durability and corrosion resistance, and the wheeled support feet facilitate easy mobility.
5-Axis Simultaneous Machining
Dedicated 5-axis DMU & Hermle centers hold blade-profile tolerance to ±0.005mm across complex freeform surfaces in a single setup — no re-fixturing errors.
ISO 13485:2016/ ISO 9001: 2015
A Quality Management System for comprehensive medical device design, development, manufacturing, and installation services, featuring an audit trail verified by Bureau Veritas. Each component is accompanied by dimensional reports, material certificates and process records.
HEXAGON CMM Full Inspection
Every Medical part is CMM-measured against 3D CAD with color deviation map. FAIR (First Article Inspection Report) available for ISO 13485:2016/ ISO 9001: 2015 customers.
Dedicated prototype lanes and DFM feedback within 48 hours of drawing receipt. We catch tolerance stack issues before you finalize design.
Raw material sourcing → machining → heat treatment coordination → finishing → CMM → export packaging. One accountable supplier.
1. Three-dimensional targeted neurosurgical surgical instruments (core scene)
2. Imaging-guided surgical equipment components
3. High-precision diagnostic/treatment equipment transmission components
4. Connecting and guiding parts of minimally invasive surgical instruments
1
Q: Which materials can you machine for femoral stems?
A: We machine 316L stainless steel (ASTM F138 / ISO 5832-1), Ti6Al4V ELI, CoCrMo, and CP-Ti. 316L offers excellent corrosion resistance and lower cost — our process controls work hardening and residual stress to avoid stress corrosion cracking.
2
Q: What tolerances can you hold?
A: Standard: ±0.002 mm for taper, ±0.010 mm for stem profile, Ra ≤ 0.05 μm for taper surface. For tighter needs, contact us — we've achieved ±0.0015 mm on certain 316L designs.
3
Q: Do you provide material traceability and certification?
A: Yes. We provide MTRs (EN 10204 3.1) for each batch, full CMM inspection, and DHR. ISO 13485:2016 certified FAIR and cleaning validation reports available upon request.
4
Q: What's the lead time for a prototype?
A: 10–20 business days after drawing approval, depending on surface finishing. DFM feedback within 48 hours of drawing receipt.
5
Q: Can you machine 316L stems with porous bone-ingrowth structures?
A: Yes. Solid, porous-coated, and fully integrated porous structures (300–800 µm pores, 60–80% porosity). For features < 0.5 mm, we use micro-milling + ECM, validated on 316L revision implants
Company Advantages
KGL Machinery & Electronics Co., Ltd has been dedicated to manufacturing medical device component manufacturers since established. Our production equipment is arranged according to the principle of lean production. They enable us to maintain the highest levels of efficiency and quality throughout the production process from product design to custom protective containers. The establishment of enterprise culture will help KGL to provide customers with the highest cost-effective services. Welcome to visit our factory!
Over the years, we have been dedicated to the R&D and production of our products. If you want to know more about our products, please contact our online customer service staff.