Medical Device CNC Machining

Sanluo Precision is a professional manufacturer and supplier of medical device CNC machining in China. With 15 years of technical experience in medical device CNC machining, it mainly engages in the precise manufacturing of Class III high-risk medical devices, providing professional customized medical device CNC machining services for customers, and supporting the customization of complex and difficult parts. The company combines regulatory compliance with exquisite craftsmanship to offer customized processing services from R&D to mass production for medical enterprises.

Send Inquiry

Product Description

Regulatory compliance system

Sanluo Precision adheres to the YY/T0287 national standard and the FDA 21 CFR 820 quality system regulations in medical device CNC machining. It has established a complete document system including design control (DHF), equipment master file (DMF), process validation (PQ), etc. Risk management (ISO 14971) is used to identify various risks existing in the processing process and corresponding preventive measures are taken. All process parameters have been verified and locked, and any changes require review and approval. CAPA (Corrective and Preventive Actions) closed-loop management is implemented to continuously improve the processing technology.

Workstation Accuracy

dimensional accuracy	OD	ID	T（C）	DP	GD
unit:±/mm	0.002	0.003	0.005	0.005	0.003
Geometric accuracy	roundness	coaxiality	straightness	cylindricity	Position tolerance
unit:±/mm	0.001	0.004	0.002	0.003	0.008
production capacity	1~999999 pcs	1~999999 pcs	1~999999 pcs	1~999999 pcs	1~999999 pcs
production cycle	3-20 days	3-20 days	3-20 days	3-20 days	3-20 days

Specialized processing equipment

As a professional manufacturer of precision medical device CNC machining, Sanluo Precision uses Swiss Tornos centering CNC lathes to process slender shaft-type medical instruments (with a L/D ratio of ≥ 10). Five-axis linkage machining center processing complex anatomical structure parts, slow-moving wire cutting processing surgical blades. The equipment is equipped with a high-precision thermal imaging system， which can monitor the cutting temperature in real time， thereby preventing changes in material properties. PCD (polycrystalline diamond) and CBN (cubic boron nitride) tools are used to reduce the frequency of tool changes and ensure batch consistency.

Biocompatibility Treatment and Application

Sanluo Precision's medical device CNC machining service offers professional surface treatment support. For titanium alloys, anodic oxidation type II treatment is carried out to form a stable TiO₂ protective film. For stainless steel, passivation treatment is applied to remove free iron and enhance corrosion resistance. For PEEK materials, plasma treatment is used to improve surface energy and enhance cell adhesion. All treated samples must undergo cell toxicity tests (ISO 10993-5), sensitization tests, and irritation tests to ensure biological safety. The company has provided customized medical device CNC machining services for neurosurgery, cardiothoracic surgery, orthopedics, dentistry, etc. The products have obtained certifications from CFDA, FDA, and CE.

Equipment technical parameters

Parameter Categories	Parameter Details
Equipment Model	Swiss XT 32/9
Brand	Tornos
Core Positioning	Multifunctional and high-performance processing of complex parts
Number of Axes	8/9 linear axes + 2 C axes; optional plug-and-play B axis
Processing Capacity	Maximum processing diameter 32 mm
Tool System	Up to 40 tools, including 18 power tool positions; 3 independent tool systems
Special Processes	Supports broaching, polygon milling/whirl milling, internal and external whirl milling, deep hole drilling, etc.
Core Advantages	Compact design, quick tool holder conversion, achieving maximum flexibility
Typical Applications	medical device CNC machining, medical and dental, electronic parts

Parameter Categories	Parameter Details
Equipment Model	MultiSwiss 6X16
Core Positioning	Efficient mass production of complex small parts
Number of Axes and Main Axis	6 main shafts + 1 optional rear main shaft
Processing Capacity	Maximum processing diameter: 16 mm
Main Axis System	Each spindle is independently controlled for speed, indexing and C-axis positioning; optional configuration allows for a maximum spindle speed of 6000 r/min.
Tool System	Each workstation can accommodate a maximum of 4 tools, and the total capacity is up to 18 tools.
Core Advantages	Multi-axis parallel processing, with production efficiency several times higher than that of single-axis lathes; optional Y-axis version
Numerical Control System	Tornos TBDECO or TISIS ISO programming software
Typical Applications	Small precision parts in industries such as medical implants, medical device CNC machining, and electronics