High-end medical devices have strict requirements for the precision, cleanliness and biosafety of core components. Investment casting is a key manufacturing process for such components.
QD Casting Factory is an expert in investment casting. It provides standard-compliant casting solutions for the medical device industry.
Four Core Advantages in the Medical Field
Investment casting has become the preferred process for high-end medical device manufacturing. This is due to the following core advantages:
| Core Advantages | Technical Features | Value in the Medical Field |
| Unparalleled Precision | Achieves ±0.1mm dimensional tolerance control. Capable of forming complex internal cavities, thin-walled and special-shaped structures | Meets the dimensional requirements of precision medical device parts. Satisfies the extremely strict dimensional requirements of surgical robots, imaging equipment, etc. |
| Excellent Surface Finish | The surface roughness (Ra) of castings is as low as 1.6μm. No need for a large amount of subsequent grinding | Easy to clean and disinfect. Avoids microbial residue and reduces the risk of cross-infection |
| Material Biocompatibility | Can cast materials that have passed medical certification, such as 316L VM stainless steel and TC4 titanium alloy | Ensures no rejection reaction of device parts that come into contact with or are implanted in the human body. Can pass biocompatibility tests |
| Integrated Forming Capability | Can cast multi-component integrated structures at one time. Reduces assembly processes such as welding and splicing | Reduces assembly links, lowers the risks caused by loosening or gaps, and improves the overall reliability of equipment |
Special Process Requirements for Medical Grade
The standard for ordinary industrial-grade investment casting cannot meet the high requirements of medical devices. QD implements special process control throughout the entire process, from melting to post-processing. The details are as follows:
Vacuum Melting Process
A vacuum induction melting furnace is used. Metal raw materials are melted in a high-vacuum environment with a vacuum degree of ≤1×10⁻³Pa. It can effectively remove gaseous impurities such as oxygen and nitrogen from the molten metal. It avoids oxide inclusions. It significantly improves metal purity and mechanical properties. It eliminates the risk of device failure caused by material impurities at the source. This is crucial for implant-grade materials.
Post – processing in Cleanroom Environment
Post – processing of castings (such as cutting, grinding, polishing, cleaning) must be carried out in a cleanroom environment. Medical-grade cleaning agents and dust-free tools are used in each process.
It ensures that there are no pollutants like dust, particles, or oil stains on the surface of castings. QD’s Class 100K clean workshop directly meets the aseptic assembly requirements of medical devices. It can meet the requirements of most medical customers.
Full – process Traceability
We establish a complete production file for each medical order. It includes:
- Qualification of raw material suppliers, furnace number inspection reports (composition, mechanical properties)
- Melting and heat treatment parameters, quality inspection data of each process
- Operation records of each process and finished product delivery inspection reports
This ensures that any quality problem can be traced back to the source. Customers can query the whole-life-cycle information of any product through the exclusive traceability code.
Typical Application Cases
Investment casting is widely used in the following medical device scenarios:
- Surgical robots: Complex structural parts such as joints, connectors, and sensor housings.
- Endoscope systems: Precision lens barrels and instrument channel components.
- Insulin pumps & infusion devices: Micro pump bodies, valves, and housings.
- Orthopedic tools & implants: Bone drill guides, spinal implants, joint prostheses, etc.
- Dental equipment: Implants and surgical instrument handles.
QD Commitment: More Than Just Casting
We fully understand that the medical industry bears the responsibility of life and health. So, we don’t just provide castings, we offer a complete quality assurance system.
We have established production and control processes that comply with the ISO 13485 Medical Device Quality Management System. We also strictly adhere to requirements of relevant regulations such as FDA and MDR. Every step, from material procurement, process design, production to final inspection, undergoes rigorous verification and documentation.
When you choose QD, you get more than just parts:
- Technical collaboration: Our engineering team gets involved early to help optimize part design for better castability.
- Compliance support: We provide full support for material certification, mechanical property testing, and biocompatibility testing.
- Stable supply: We have the capability to seamlessly switch from small-batch prototyping to large-scale production.
Summary
With its high precision, excellent surface quality and material flexibility, investment casting has become an indispensable part of high-end medical device manufacturing. As medical technology continues to move toward minimally invasive and intelligent development, the value of investment casting processes will become even more prominent.
QD has always conducted production in accordance with medical-grade standards. In the future, we will continue to increase investment to provide more reliable and safer casting solutions for high-end medical device companies worldwide.
FAQ
1. Can Investment Casting Meet the Standards for Medical Implants?
Yes. Through vacuum melting, strict material selection and full-process cleanliness control, investment casting can produce implant-grade parts that comply with standards such as ASTM F136 and ISO 5832.
2. What Are the Minimum Castable Size and Tolerance?
For typical medical castings, the minimum wall thickness can reach 0.5mm, and the dimensional tolerance can reach ±0.075mm. The specific values depend on the part’s geometry and material.
3. What Medical Compliance Certifications Do You Support?
We comply with the ISO 13485 quality management system. We can also provide manufacturing records and material reports that meet the requirements of FDA 21 CFR Part 820 and EU MDR.
4. Do You Support Prototyping and Small-Batch Production?
Yes. We provide flexible services ranging from rapid prototyping to batch production. We are especially skilled in handling multi-variety, small-batch orders commonly required by medical clients.
5. Does Post-Processing Include Machining and Polishing?
Yes. We offer a full range of post-processing services, including CNC precision machining, sandblasting, and electrolytic polishing. This ensures parts meet assembly requirements.
6. How Do You Ensure Part Traceability?
We use a full-process traceability system from material warehousing to finished product delivery. Each part can be traced back to its original heat number, production shift, and inspector.