Stainless Steel Medical Application OEM – Contract Manufacturing for Surgical Instruments
Medical Application Contract Manufacturing: Your Trusted OEM Partner
Stainless steel medical device OEM (Original Equipment Manufacturer) and contract manufacturing services enable medical device companies to bring innovative products to market faster, with lower capital investment, and with guaranteed quality. As an experienced stainless steel medical device OEM manufacturer, we provide end-to-end manufacturing solutions from design support to finished, packaged devices.
Our Manufacturing Capabilities
Core Processes
| Process | Capabilities | Applications |
|---|---|---|
| CNC Machining | Turning, milling, drilling, ±0.01mm tolerance | Surgical instruments, implants, device housings |
| Cold Drawing | Capillary tubes OD 0.1-6.0mm, wall 0.025-0.5mm | Needles, catheter components, sensing tubes |
| Laser Cutting | Micro-precision cutting, burr-free, ±0.05mm | Stents, shaver blades, micro-fluidic channels |
| Grinding & Polishing | Bevel grinding, electropolishing, Ra ≤0.2μm | Needle tips, cutting edges, surgical blades |
| Heat Treatment | Hardening, annealing, stress relief | 420J2/440C blades, springs, structural components |
| Laser Welding | Micro-welding, TIG welding, precision assembly | Needle hubs, sensor assemblies, device integration |
| Surface Treatment | Electropolishing, passivation, DLC/TiN coating | Corrosion resistance, lubricity, wear resistance |
Materials We Process
| Grade | Standard | Key Properties |
|---|---|---|
| 304 | ASTM A269 | General purpose, cost-effective, good corrosion resistance |
| 316L | ASTM A269 | Superior corrosion resistance, low carbon, weldable |
| 316LVM | ASTM F138 / ISO 5832-1 | Biocompatible, fatigue resistant, implant grade |
| 420J2 | ASTM A276 | High hardness (50-55 HRC), wear resistant |
| 440C | ASTM A276 | Ultra-high hardness (58-62 HRC), premium cutting |
| 17-4PH | ASTM A564 | Precipitation hardening, high strength, corrosion resistant |
Product Categories
Surgical Instruments
- Laparoscopic instruments (graspers, dissectors, scissors, clip appliers)
- Orthopedic instruments (drill guides, reamers, saw blades)
- Neurosurgical instruments (probes, retractors, needle holders)
- Dental instruments (scalers, probes, forceps)
Needles & Cannulae
- Hypodermic needles (25G-32G)
- Biopsy needles (core, FNA)
- Acupuncture needles
- Cannulae and catheter components
Shaver Blades & Rotating Instruments
- Arthroscopic shaver blades (2.0mm-5.0mm)
- Neurosurgical shaver blades
- ENT shaver blades
- Dental burs and drills
Implantable Components
- Pacemaker lead components
- Stent delivery system components
- Orthopedic fixation components
- Spinal instrumentation components
Quality & Compliance
| Standard | Description |
|---|---|
| ISO 9001:2016 | Medical device quality management system |
| ISO 9001:2015 | Quality management system |
| ISO 10993 | Biocompatibility evaluation |
| FDA 21 CFR Part 820 | Quality System Regulation (QSR) |
| EU MDR 2017/745 | Medical Application Regulation |
| EN 10204 3.1 | Material certification |
OEM Process
- Design Review & DFM — Design for manufacturability analysis, material selection, cost optimization
- Prototyping — Rapid prototyping (2-4 weeks), design validation, performance testing
- Tooling & Process Development — Custom tooling, process validation, PPAP documentation
- Production — Full-scale manufacturing with 100% inspection, traceability, SPC monitoring
- Quality Assurance — In-process inspection, final inspection, material test reports, CoC
- Packaging & Delivery — Cleanroom packaging, sterile or non-sterile, on-time delivery
Why Partner With Us?
| Advantage | Details |
|---|---|
| 20+ Years Experience | Specialized in stainless steel medical device manufacturing |
| Full In-House Capability | Design → prototyping → tooling → production → inspection → packaging |
| Quality First | ISO 9001 certified, FDA registered, comprehensive documentation |
| Competitive Pricing | Direct manufacturer, no middleman, volume discounts |
| Fast Turnaround | 2-4 weeks prototyping, 4-8 weeks production |
| IP Protection | NDA, confidentiality agreement, secure data handling |
Request a Quote
Contact us with your product specifications, drawings, or concepts. Our engineering team will provide a comprehensive DFM review and competitive quote within 24 hours. Free prototyping samples available for qualified projects.
Healsmed
Leading Stainless Steel Capillary Tube Factory. 1,400+ standard sizes IN STOCK & ready to ship worldwide! High precision, factory-direct price.
