Medical Grade Stainless Steel Parts
Quick Specifications
Material
316L, 17-4 PH, 304L
Process
CNC Machining
Tolerance
±0.005mm
Lead Time
5-10 days
MOQ
10 pieces
Surface Finish
Electropolished, Passivated
Material
316L, 17-4 PH, 304L
Process
CNC Machining
Tolerance
±0.005mm
Lead Time
5-10 days
MOQ
10 pieces
Surface Finish
Electropolished, Passivated
Sinbo Precision specializes in manufacturing medical grade stainless steel parts that meet the highest standards of quality and biocompatibility. Our ISO 13485 certified quality management system ensures that every component we produce adheres to stringent medical device regulations and requirements. We work with medical grade stainless steels including 316L, 17-4 PH, and 304L, which are widely used in surgical instruments, implantable devices, and diagnostic equipment.
Our advanced CNC machining capabilities include 5-axis milling, Swiss turning, and micro-machining for ultra-precise medical components. We maintain tight tolerances of ±0.005mm and offer specialized surface finishes such as electropolishing and passivation to enhance biocompatibility and corrosion resistance. Our cleanroom manufacturing environment and rigorous quality control processes ensure contamination-free production of medical device parts.
We support medical device manufacturers from prototype development through full-scale production. Our engineering team provides comprehensive DFM (Design for Manufacturing) support optimized for medical applications, ensuring regulatory compliance and cost-effective production. With FDA compliant processes and full traceability documentation, we help our customers navigate the complex regulatory landscape of the medical device industry.
| Material Grades | 316L, 17-4 PH, 304L, 316LVM, 420 Medical Grade Stainless Steel |
| Process | CNC Milling, Swiss Turning, Micro-Machining, 5-Axis Machining |
| Tolerance | ±0.005mm (±0.0002") |
| Surface Finish | Electropolished (Ra 0.4), Passivated, Mirror Polished |
| Size Range | Micro-components to 300mm diameter |
| Lead Time | 5-10 days (standard), 3-5 days (express) |
| MOQ | 10 pieces (prototypes), 100 pieces (production) |
| Certifications | ISO 13485, ISO 9001, FDA Compliant, IATF 16949 |
Low carbon version of 316 with excellent corrosion resistance and biocompatibility. Widely used for surgical instruments and implantable devices.
Precipitation hardening stainless steel with high strength and hardness. Used for surgical tools, dental instruments, and orthopedic devices.
Low carbon austenitic stainless steel with excellent formability and corrosion resistance. Suitable for non-implantable medical devices.
Vacuum melted 316L with ultra-low impurity levels. Premium grade for critical implantable applications and surgical instruments.
Martensitic stainless steel with high hardness and wear resistance. Used for cutting instruments, scalpels, and surgical blades.
We can machine various specialty medical grade stainless steel alloys based on your specific application requirements and specifications.
Scalpels, forceps, retractors, clamps, and precision surgical tools requiring sharp edges and durability
Joint replacement components, bone screws, plates, and fixation devices for orthopedic applications
Dental tools, orthodontic components, implant abutments, and precision dental device parts
Stents, catheter components, valve parts, and precision cardiovascular medical device components
Precision components for diagnostic instruments, imaging equipment, and laboratory devices
Surgical table components, hospital bed parts, and medical equipment hardware requiring precision and durability
Medical Device QMS
Compliant
Traceability
Manufacturing
ISO 13485:2016
ISO 9001:2015
IATF 16949:2016
ISO 14001:2015
Our minimum order quantity is 10 pieces for prototypes and 100 pieces for production runs. We can accommodate lower quantities for medical device development projects with appropriate documentation and quality requirements.
Standard lead time is 5-10 days for medical grade stainless steel parts. Express service with 3-5 day turnaround is available for urgent projects. Lead times may vary based on complexity, quantity, and quality requirements.
Yes, we are ISO 13485:2016 certified for medical device manufacturing. Our quality management system is designed to meet the specific requirements of the medical device industry, including regulatory compliance and traceability.
Yes, we provide full material traceability including mill certificates, heat lot numbers, and complete documentation for all medical grade stainless steel materials used in production. This ensures regulatory compliance and quality assurance.
We offer electropolishing (Ra 0.4 or better), passivation, mirror polishing, and bead blasting. Electropolishing is particularly recommended for medical parts as it enhances biocompatibility, removes surface contaminants, and improves corrosion resistance.
Marine-grade stainless steel for harsh environments
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Get a free quote within 24 hours. ISO 13485 certified manufacturing.