Machining Medical Parts Manufacturing Service

Manufacturing Insight: Machining Medical Parts

Precision CNC Machining for Critical Medical Applications

Honyo Prototype delivers advanced CNC machining services engineered specifically for the stringent demands of medical device manufacturing. Our ISO 13485-certified facility combines multi-axis milling and turning capabilities with rigorous process controls to produce complex components requiring micron-level tolerances, biocompatible finishes, and full material traceability. From surgical instruments and orthopedic implants to diagnostic equipment housings and fluidic systems, we machine mission-critical parts in titanium, stainless steel, PEEK, and other regulated materials under controlled cleanroom environments. Every process adheres to FDA QSR and ISO 10993 standards, ensuring compliance from prototype through volume production.

Our technical expertise extends beyond machining to comprehensive DFM support, first-article inspection reports (FAIR), and serialized part tracking—eliminating regulatory risk while accelerating time-to-market for Class I, II, and III devices. To streamline your procurement workflow, Honyo provides an Online Instant Quote platform where medical OEMs and contract manufacturers can upload CAD files, specify materials and tolerances, and receive detailed, binding cost estimates within hours—not days. This transparency empowers rapid prototyping decisions without compromising the precision or compliance essential to healthcare innovation.

Partner with Honyo to transform medical device concepts into validated, production-ready components with engineering rigor you can measure.

---

Technical Capabilities

Honyo Prototype delivers precision machining services for medical components requiring high accuracy, biocompatibility, and repeatable performance. Our capabilities in 3/4/5-axis milling and CNC turning are optimized for tight-tolerance parts used in surgical instruments, implants, diagnostic devices, and drug delivery systems. We work with a range of materials commonly used in the medical industry, including aluminum, stainless steel, ABS, and nylon, ensuring compliance with industry standards and cleanroom-compatible finishing when required.

Below are the technical specifications for machining medical parts:

Parameter	Specification
Machining Processes	3-Axis, 4-Axis, and 5-Axis CNC Milling; CNC Turning (Swiss and Standard)
Tolerance Capability	±0.0002″ (5 µm) for critical features; typical tight tolerance ±0.001″ (25 µm)
Surface Finish	As machined: 32–125 µin Ra; polishing available down to 8 µin Ra
Materials – Metals	Aluminum 6061, 7075; Stainless Steel 316, 17-4 PH; Titanium (Grade 5)
Materials – Plastics	ABS, Nylon (PA6, PA66), PEEK, Delrin (POM), Polycarbonate
Max Work Envelope (Milling)	5-Axis: 760 x 460 x 410 mm; 3/4-Axis: up to 800 x 500 x 500 mm
Max Turning Diameter	38 mm (Swiss-type); up to 300 mm (standard turning)
Tooling & Probing	High-precision carbide tooling; in-process probing for feature verification
Inspection Equipment	CMM, optical comparators, micrometers, bore gauges, surface roughness testers
Compliance & Cleanliness	ISO 13485 support; cleanroom assembly and packaging available upon request

All medical components are machined with strict process controls, including first-article inspection (FAI) and batch traceability. Honyo Prototype supports low-to-medium volume production with rapid turnaround, ensuring scalability and consistency for regulatory-compliant medical device manufacturing.

---

From CAD to Part: The Process

CAD File Submission and Initial Assessment
Clients initiate the process by uploading native CAD files or industry-standard formats such as STEP or IGES through Honyo’s secure customer portal. Our system immediately performs an automated integrity check to verify geometric completeness, unit consistency, and file compatibility with ISO 10303 standards. For medical components, we specifically flag requirements related to biocompatible materials, surface finish specifications per ASTM F86, and critical feature annotations essential for regulatory compliance.

AI-Powered Quoting Engine
Honyo’s proprietary AI quoting system analyzes the CAD geometry, material specifications, and client-provided requirements within 15 minutes. The algorithm cross-references real-time data on machine availability, material costs for medical-grade alloys (e.g., ASTM F138 stainless steel, Ti-6Al-4V ELI), and secondary process costs. Crucially, the AI identifies potential regulatory touchpoints such as ISO 13485 documentation needs, sterilization compatibility notes, and metrology requirements for critical dimensions. Clients receive a detailed quote including lead time breakdown, material traceability protocols, and explicit assumptions regarding biocompatibility certifications.

Medical-Focused DFM Analysis
Our engineering team conducts a rigorous Design for Manufacturability review with medical device-specific parameters. Unlike standard DFM, this phase emphasizes:

Standard DFM Element	Medical-Specific Enhancement
Tool access validation	Evaluation of burr-sensitive areas per ISO 137 requirement
Wall thickness assessment	Analysis of sterilization-induced stress points (e.g., steam, EtO)
Tolerance stack-up review	Verification against FDA QSR 820.25 process validation thresholds
Surface finish feasibility	Confirmation of Ra values compliant with implantation standards

The DFM report includes actionable recommendations such as modifying sharp corners to prevent stress corrosion cracking in saline environments or adjusting tolerances to accommodate post-machining passivation. Clients receive annotated CAD markups with justifications tied to regulatory expectations.

Precision Production Execution
Machining occurs in ISO Class 8 cleanrooms using certified medical-dedicated equipment. All processes adhere to documented work instructions compliant with ISO 13485:2016 clause 7.5. Key protocols include:
Machines undergo daily Cpk validation for critical dimensions with minimum process capability of 1.67.
Material batches are quarantined until Mill Test Reports and CoC documentation are verified against client specifications.
In-process inspections use calibrated CMMs with NIST-traceable certificates, focusing on critical-to-quality features identified during DFM.
Post-machining, parts undergo mandatory cleaning per ASTM F86 and passivation per AMS 2700, with documentation of solution concentration and dwell times.

Regulatory-Compliant Delivery
Final shipment includes a comprehensive documentation package meeting FDA 21 CFR Part 820 and MDR Annex Z requirements:
Device History Record (DHR) with full traceability from raw material lot to finished part
Signed Certificate of Conformance with explicit reference to applicable standards
Sterilization compatibility report detailing residual testing methodology
Dimensional inspection reports showing all critical features against drawing tolerances
All packaging follows ISO 11607-1 for sterile barrier systems when applicable. Parts ship in validated transit containers with environmental monitoring data to ensure integrity during transport.

Honyo’s end-to-end process for medical components integrates speed with uncompromised regulatory rigor, ensuring every part meets the dual demands of precision manufacturing and life-science compliance. Our closed-loop system provides clients with full visibility while maintaining the audit trails required for medical device submissions.

---

Start Your Project

Looking for precision machining of medical parts? Partner with Honyo Prototype for high-accuracy, ISO-compliant manufacturing tailored to the medical industry’s strict standards. Our Shenzhen-based factory is equipped with advanced CNC technology and a quality-driven process to deliver reliable, repeatable results for prototyping and low-to-mid volume production.

Contact Susan Leo to discuss your project requirements
Email: [email protected]
Factory location: Shenzhen, China

---