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Medical Device Casting

Medical Device Casting

We are a professional medical device casting manufacturer, dedicated to providing high-precision investment casting and precision casting solutions for global medical device customers. We produce biocompatible metal castings from Ti-6Al-4V titanium alloy, medical-grade 316L stainless steel, cobalt-chromium alloy (CoCrMo), and nickel-titanium (Nitinol).
Our investment-cast medical parts achieve precision tolerances of ±0.05 mm, surface roughness as low as Ra ≤ 0.8 μm, and support multiple sterilization methods including high-pressure steam (autoclave), ETO, and gamma irradiation. From hand-held surgical instruments to minimally invasive surgical components, we provide every customer with complete material traceability and rigorous quality control — ensuring every casting can be safely applied in clinical environments.
By choosing us, you receive not only high-quality biocompatible metal castings, but also reliable one-stop support from DFM analysis through to mass production delivery.
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Description

Core Capabilities

 

Our precision-cast medical devices are engineered specifically for the demanding requirements of the healthcare industry:

Precision to ±0.05 mm -

 Fine investment casting (lost-wax process) achieves stable repeatability for complex geometries, minimizing the need for secondary machining

01

Surface roughness Ra ≤ 0.8 μm -

 After electropolishing, parts meet implant-grade brightness requirements and reduce bacterial adhesion risk

02

Full compliance framework -

 Conformant with ISO 13485 and FDA 21 CFR Part 820; complete material traceability (Heat Number) and CoC reports provided for every batch

03

15-day sample lead time -

From DFM analysis to first article, fastest completion in 15 working days, significantly shortening product certification cycles

04

Broad material portfolio -

Medical-grade Ti-6Al-4V, 316L stainless steel, CoCrMo, and Nitinol to meet diverse device performance requirements

05

 

Material Selection Guide

 

Selecting the correct casting material is critical to medical device performance. The table below provides engineering-level data based on ASTM/ISO medical specifications:

Material

Biocompatibility (ISO 10993)

Corrosion Resistance

Sterilization Methods

Tensile Strength (MPa)

Hardness (HV)

Density (g/cm³)

Typical Applications

**Ti-6Al-4V ELI**

Compliant (Implant Grade)

Excellent

Autoclave, ETO, Gamma, VH₂O₂

860–965

300–380

4.43

Orthopedic implants, surgical tools

**316L Stainless Steel**

Compliant (Class I–III)

Very Good

Autoclave, ETO, Gamma, VH₂O₂

485–620

150–200

7.96

Surgical instruments, fixation plates

**Cobalt-Chrome (CoCrMo)**

Compliant (Implant Grade)

Outstanding

Autoclave, ETO, Gamma

700–900

300–450

8.30

Joint prostheses, dental components

**Nickel-Titanium (Nitinol)**

Compliant (ISO 10993-5/10)

Very Good

ETO, Gamma, VH₂O₂ *(limited Autoclave)*

800–1,000 (superelastic)

250–350

6.45

Cardiovascular stents, guidewires

Selection guidance: For over 90% of implant projects, Ti-6Al-4V ELI or CoCrMo is the recommended choice. Complete material datasheets, batch testing reports, and ISO 10993 biocompatibility test reports are available on request.

 

Precision & Quality Control

 

Every medical device casting undergoes a rigorous multi-stage inspection process to ensure compliance with medical-grade standards:

  • CMM three-axis measurement - Accuracy ±0.01 mm, fully traceable
  • X-ray inspection - Internal defect detection (porosity, inclusions, cracks)
  • Metallographic analysis - Microstructure verification
  • Surface roughness & dimensional full inspection - 100% parts checked

The quality documentation system includes First Article Inspection (FAI) reports, Batch Inspection Reports (CoC), and complete material heat number traceability - strictly adhering to ISO 13485:2016 clauses 7.1–7.5 and FDA 21 CFR Part 820 Subpart G requirements.

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Sterilization Compatibility

 

Medical device castings must support the sterilization methods used by end-users. The table below summarizes compatibility by material:

Sterilization Method

Ti-6Al-4V ELI

316L Stainless Steel

CoCrMo

Nitinol

**Autoclave (134 °C steam)**

✅ Fully compatible

✅ Fully compatible

✅ Fully compatible

⚠️ Evaluate cycle count

**ETO (Ethylene Oxide)**

✅ Compatible

✅ Compatible

✅ Compatible

✅ Compatible

**Gamma Irradiation**

✅ Recommended

✅ Compatible

✅ Recommended

✅ Compatible

**VH₂O₂ (Plasma / Low-temp)**

✅ Compatible

✅ Best compatibility

✅ Compatible

✅ Compatible

Surface treatments such as electropolishing + passivation significantly improve corrosion resistance and biocompatibility post-sterilization. We provide complete validation data for ETO and autoclave sterilization compatibility.

 

Manufacturing Capabilities

 

Our investment casting medical parts utilize fine lost-wax casting and comprehensive post-processing:

  • Fine lost-wax casting - Tolerance ±0.05 mm; supports complex structures with minimum wall thickness of 0.5 mm
  • Silica sol shell casting - Achieves superior surface brightness (Ra ≤ 0.4 μm)
  • CNC precision machining - Auxiliary key dimensions reach ±0.01 mm
  • Surface treatments - Electropolishing, sandblasting, passivation, PVD coating

Key equipment: Wax injection machine, vacuum induction melting furnace, ceramic shell preparation line, coordinate measuring machine (CMM), X-ray flaw detector. FDA QSR conformity declaration and CE Mark support available.

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Customization Process

 

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Requirements evaluation & NDA signing *(1–2 business days)* - Sign mutual NDA; receive and review 3D files and technical specifications

 

DFM analysis *(48-hour response)* - Return casting feasibility report and optimization recommendations

 

 

Wax pattern fabrication & trial casting *(10–12 days)* - Deliver first article samples and FAI report

 

 

Inspection report confirmation - Customer reviews CoC, dimensional report, and biocompatibility data

Mass production & ongoing quality monitoring - Batch production with per-batch inspection and stable delivery schedule

 

Application Scenarios

 

Application

Details

**Surgical Instruments**

316L stainless steel clamp components; high surface brightness; validated for **200+ repeated sterilization cycles**

**Cardiovascular Stent Components**

Nitinol precision-cast stent parts combining superelasticity and biocompatibility

**Dental Castings**

CoCrMo denture frameworks with high precision and corrosion resistance

**Endoscope Components**

Miniature 316L stainless steel housings with thin walls and complex internal geometry

**Diagnostic Equipment Housings**

Lightweight titanium alloy precision castings meeting EMC and cleanliness requirements

**Rehabilitation Robot Joints**

CoCrMo joint components providing high strength and low-friction articulation

**Minimally Invasive Instruments**

Biocompatible metal castings supporting repeated ETO or gamma sterilization

 

FAQ

 

What is the minimum order quantity for medical device castings?

Prototype quantities start from 1 piece (CNC or rapid casting). Mass production MOQ for investment casting is typically 500–2,000 pieces, depending on part size. We offer bridge production solutions to quickly support clinical validation needs.

Have materials undergone ISO 10993 biocompatibility testing?

All medical-grade materials (Ti-6Al-4V, 316L, CoCrMo, Nitinol) are supplied with complete third-party ISO 10993-1, -5, -6, -10, -11 test reports covering cytotoxicity, sensitization, implantation, and systemic toxicity testing.

What sterilization methods are supported? Is compatibility validation available?

We support high-pressure steam (autoclave), ETO, gamma irradiation, and low-temperature plasma (VH₂O₂) sterilization. We provide specific sterilization cycle validation reports for each material and can develop customized validation plans aligned with your SOPs.

Do you sign NDAs for proprietary medical device designs?

Yes. A mutual NDA can be executed upon first contact. All drawings, specifications, and process details are strictly confidential, in full compliance with medical device industry IP protection requirements.

Who owns the tooling and fixtures?

In mass production orders, all wax tooling and fixtures remain the property of the customer. We store and maintain them at no additional charge for the life of the program.

What are the lead times, and what documentation is provided?

First article samples: 15 business days. Mass production: 4–6 weeks. Each batch is delivered with FAI report, CoC, material certificates, dimensional report, and X-ray inspection report - available in PDF and compatible with electronic quality management system integration.

 

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