Sanluo Precision is a specialized manufacturer and supplier of medical CNC machining services in China, dedicated to providing the global medical device industry with high-precision, highly reliable, and customized machining solutions. We also offer clients a comprehensive, end-to-end service—spanning auxiliary part design, machining, assembly, and debugging. Over the years, the company has directly or indirectly provided customized machining services to renowned enterprises such as GE Healthcare and Mindray Medical, specializing in the fabrication of complex and challenging components.
We provide customized machining services for various medical disciplines, including neurosurgery, cardiothoracic surgery, cardiovascular care, orthopedic implants, interventional cardiology, neuromodulation, ophthalmic implants, and dentistry. Our primary areas of focus include minimally invasive surgical instruments, implantable medical devices, and high-precision medical equipment. By prioritizing speed, quality, cost-efficiency, and exceptional service, we ensure reliable delivery capabilities, thereby earning the deep trust and long-term recognition of our clients.
Medical CNC machining demands exceptionally high standards regarding precision, cleanliness, biocompatibility, and structural stability. Sanluo Precision specializes in the precision machining of medical components, with core service categories including general medical CNC machining, medical device component machining, and precision medical screw machining. We focus on the customized production of components for medical devices, aesthetic medical equipment, and human implants, excelling in the precision machining of compliant materials such as TC4 titanium alloy, medical-grade stainless steel, and medical-grade engineering plastics. Leveraging high-precision CNC equipment and a mature process framework, we can achieve dimensional tolerances of ±0.001mm and produce surfaces with extremely low roughness.
We strictly adhere to medical product manufacturing regulations, establishing rigorous quality control standards across every stage—from machining processes, full dimensional inspections, and visual inspections to air-tightness testing. This enables us to supply the medical industry with safe, reliable, and dimensionally stable high-precision CNC-machined parts that fully meet clinical application requirements, thereby facilitating quality upgrades and technological innovation in medical device products.
Sanluo Precision’s manufacturing facility operates in strict adherence to medical CNC machining standards. We specialize in the long-term processing of biocompatible materials—including medical-grade 316L stainless steel, TC4/TA1 titanium alloys, cobalt-chrome alloys, and PEEK—all of which have successfully passed relevant ISO 10993 testing protocols, meeting all requirements for cytotoxicity, sensitization, and irritation. The dimensional tolerances of our machined parts are consistently controlled within a range of ±0.002 mm to ±0.005 mm, with a surface roughness (Ra) ranging from 0.1 μm to 0.8 μm.
Our parts are free of burrs and sharp edges; furthermore, we are capable of machining minimum fillet radii ranging from R0.02 mm to R0.5 mm—precisely as specified in client drawings—to fully meet customer requirements. We rigorously enforce material application specifications, recognizing that material compliance constitutes the absolute minimum requirement for precision medical CNC machining.
If medical-grade CNC components were processed using the same cleaning standards applied to general industrial parts, they would fail to meet the requisite cleanliness criteria—thereby rendering them unsuitable for clinical application. Sanluo Precision employs a comprehensive cleaning protocol that includes medical-grade ultrasonic cleaning, rinsing with purified water, disinfection using 90% ethanol, and sterile packaging following a drying process. We strictly control for residual oil and particulate matter, executing critical processing stages within a Class 100,000 cleanroom environment to minimize the risk of microbial and particulate contamination.
Specifically for implantable devices—building upon the foundation of non-toxic materials—we utilize processes such as surface passivation and precision polishing to control the surface roughness of implant components to Ra < 0.1 μm. This approach balances the requirements for osseointegration and long-term stability, ensuring that our custom medical CNC machining services fully satisfy the specific cleanliness requirements stipulated in our clients' engineering drawings.
To provide clients with the highest quality custom machining services, Sanluo Precision has established a comprehensive system of equipment and processes. Our 5-axis machining centers are utilized for processing the complex curved surfaces of orthopedic implants; for titanium alloy hip and knee joints, we achieve a precision tolerance of ±0.005 mm and a surface roughness superior to 0.2 μm. Our precision CNC lathes are dedicated to machining orthopedic screws and intramedullary nails, handling outer diameters ranging from φ0.5 mm to 10 mm with Grade 6 thread precision and a surface roughness of Ra 0.1 μm.
Additionally, our Swiss-type lathes are employed for machining slender surgical instruments—specifically shafts with a length-to-diameter ratio of ≥30:1—maintaining concentricity within 0.002 mm. Furthermore, the company is equipped with high-precision laser cutters for slicing nickel-titanium shape memory alloy stents; these cutters produce a kerf width of approximately 0.01 mm and a heat-affected zone of less than 0.05 mm, thereby ensuring exceptional geometric accuracy and providing a robust hardware foundation for precision CNC medical machining and medical micromachining for implants.
If a quality management system fails to comply with international regulations, even if the manufactured parts meet precision specifications, it remains difficult to support a client's regulatory registration and compliance requirements. Sanluo Precision’s medical CNC machining services operate in strict accordance with the ISO 13485 Quality Management System for Medical Devices, incorporating ISO 14971 for risk management. Our traceability system covers critical information—including material batches, process parameters, and inspection records—enabling us to support FDA registration and the preparation of EU MDR technical documentation, as well as to assist clients with 510(k) submissions, validation, and the compilation of preclinical testing data. Regarding cleaning validation, we rigorously test for particulate matter, endotoxins, and microbial limits following the cleaning process. For packaging and sterilization, we utilize medical-grade packaging materials and support sterilization via ethylene oxide (EtO) or irradiation, achieving a Sterility Assurance Level (SAL) of 10⁻⁶.
In terms of specific medical applications, Sanluo Precision has served as a long-term, high-volume supplier for a wide range of products—including orthopedic implants, joint prostheses, surgical scalpels, and drill bits—producing hundreds of thousands of medical components annually with a consistent acceptance rate of 99.9%. As a medical CNC machining manufacturer and supplier rooted in China, we consistently provide reliable custom machining services to global medical clients, leveraging traceable data, stable processes, and a compliance-oriented quality system.
