High-Precision Medical Device Components Manufacturing
TDB Tech is your trusted partner for manufacturing ISO 9001-certified parts. We also hold ISO 13485 certification for manufacturing parts for medical devices, such as hearing aids.
We apply this quality management system (aligned with medical standards) to all our medical manufacturing projects. You can obtain precision parts that meet the highest standards—without paying extra for cleanroom costs.
Precision Medical Components We Manufacture
With dual-certified manufacturing facilities in China and Mexico, TDB Tech has delivered precision medical components since 2012 for 300+ MedTech innovators. Our cross-functional engineering team combines medical device regulatory expertise with advanced manufacturing technologies to become your extended production arm.
Diagnostic & Laboratory Instruments
- Housings for blood analyzers
- Components for PCR equipment
- Panels for lab automation systems
Medical Imaging & Monitoring Equipment
- External components for ultrasound probes
- Durable monitor enclosures
- Connectors for patient monitoring systems
Therapeutic & Surgical Support Devices
- High-precision gears for ventilator mechanics
- Housings for handheld therapy devices
- Components for rehabilitation chairs
Wearable & Personal Medical Devices
- Components for medical hearing aids
- Frames for wearable health trackers
- Parts for insulin pump controllers
Trusted Medical Parts Making Case Studies
Notes: Due to the NDA signed with our clients on most projects, we are only able to select and display the appearances of a few products from the medical industry after obtaining consent through communication with our clients.
Diagnostic and Monitoring Device Parts
Diagnostic Device Housing
| Process: | Mold Making, Injection Molding |
| Materials: | ABS |
| Solutions: | Mass Production |
| Tolerance: | ±0.005″ |
Medical lighting tool housings
| Process: | Mold Making, Injection Molding |
| Materials: | PC+ABS |
| Solutions: | Mass Production |
| Tolerance: | ±0.005″ |
Support and Mobility Device Parts
Hearing aids
| Process: | Production Tooling, Injection Molding |
| Materials: | PC+ABS |
| Solutions: | Mass Production |
| Tolerance: | ±0.005″ |
Rehabilitation chair components
| Process: | CNC Machining |
| Materials: | Zinc Alloy |
| Solutions: | Mass Production |
| Tolerance: | ±0.002″ |
One-Stop Suite of Medical Precision Manufacturing Capabilities
Medical Plastic Injection Molding
Ideal for high-volume production of diagnostic equipment housings, laboratory instrument panels, and durable monitor bezels . Particularly suitable for customers requiring cost-effective, geometrically complex parts in medical-grade polymers.
- Material Compliance: PP, ABS, COC with USP Class VI certification.
- Precision Molding: Tolerances to ±0.05mm for critical interfaces.
- Scalability: 50-1000 ton presses for 10K-5M+ part volumes.
Medical Precision CNC Machining
The optimal solution for functional prototypes, low-to-mid volume production runs, and geometrically complex parts. It’s suitable for aluminum chassis for imaging systems, stainless steel structural brackets for medical carts, and high-performance PEEK components for reusable diagnostic tools.
- Metals & Plastics: Aluminum 6061/7075, Titanium, and PEEK.
- 5-Axis Precision: Tight tolerances as ±0.005mm accuracy.
- Full Surface Finish: 20+ types of surface finishing options.
Medical-Grade Tooling Systems
Critical for mass production of diagnostic test cartridges, pipette trays, and device enclosures. Designed for manufacturers needing high-cavitation molds with accelerated sampling cycles and validated tool performance.
- Mold Longevity: 1M+ shots with hardened tool steels.
- Rapid Sampling: First shots in 7-15 days.
- Micro-Features: EDM capabilities for <0.5mm details
Medical Plastic Injection Molding
Accelerates development of surgical guides, diagnostic device housings, and ergonomic handpiece designs. Best for R&D teams needing functional prototypes or bridge production before injection molding validation.
- Medical Metals: 316L stainless steel, Ti6Al4V (ASTM F136)
- Micro-Precision: ±0.005mm accuracy with 5-axis milling.
- Full Surface Finish: 20+ types of surface finishing options.
Surface Finishing Options
- 20% average cost savings.
- Single-point quality accountability
- Full sterilization compatibility reports
| Surface Treatment | Effect on Medical Components | Typical Medical Part Applications |
|---|---|---|
| Bead Blasting | Creates a uniform, non-glare matte texture for improved handling. | Housings for handheld diagnostic devices, equipment panels. |
| Pad Printing | Applies durable, wear-resistant markings, logos, and instructions. | Equipment control panels, reusable instrument handles. |
| Electropolishing | Produces ultra-smooth surfaces reducing bacteria. | Reusable stainless steel lab trays, instrument chassis. |
| Passivation | Enhances the corrosion resistance of stainless steel components. | Structural brackets, fasteners, and internal support frames. |
| Anodizing | Forms protective oxide layer for color coding. | Aluminum instrument panels, monitor housings, equipment knobs. |
| PVD Coating | Creates an ultra-hard, wear-resistant surface for moving parts. | High-wear components in diagnostic machinery, robotic arms. |
| Silicone Spray Coating | Adds a soft-touch, non-slip finish for improved ergonomics. | Handles for portable medical devices, patient-contact surfaces. |
| Powder Coating | Provides durable chip-resistant protective layer. | Medical cart frames, equipment chassis, and support structures. |
Medical Component Partnership Workflow
The manufacturing process of medical parts is not complicated. Throughout the entire process, all you may need to do is upload the 3D drawings and maintain communication with us.
1. Project Review & Technical Consultation
2. In-Depth Medical Parts DFM Analysis
3. Tooling Making / CNC Machining
4. Secure Packaging & Global Delivery
Medical Component Partnership Workflow
Material Option for Medical Parts Manufacturing
The medical device and healthcare industry is distinct from other sectors: many products are directly applied to the human body. So we strictly adhere to industry standards in our use of materials. Although this approach leads to a certain amount of raw material waste, we consistently refuse to use recycled materials for injection molding production, and this standard is upheld in the manufacturing of parts for other industries as well.
We can provide raw material certification for all processing methods and can also purchase from suppliers specified by clients. Our expertise includes the following raw materials:
| Material Category | Specific Materials | Medical Certifications | Key Applications |
|---|---|---|---|
| High-Performance Polymers | PEEK, PPSU, PEI, PPS | ISO 10993, USP Class VI, FDA 21 CFR | Reusable instrument handles, structural components for diagnostic machines, manifolds. |
| Engineering Plastics | PC, POM, UHMWPE, COC | FDA, ROHS, REACH compliant | Diagnostic equipment housings, optical-grade covers and lenses, durable moving parts. |
| Medical Metals | 316L Stainless Steel, Ti6Al4V (Grade 5/23), CoCrMo | ASTM F138/F139, ISO 5832-3 | Structural frames for medical carts, equipment chassis, non-implant surgical tool components. |
| General Plastics | ABS, PP, HDPE, PVC, PS, Nylon (PA6/66) | ROHS, REACH | Enclosures for lab equipment, non-contact covers and panels, functional prototypes. |
| Engineering Alloys | Aluminum 6061-T6, Brass C360 | ISO 9001, ASTM B221 | Chassis for diagnostic equipment, heat sinks, connectors and fittings. |
| Medical Elastomers | Platinum LSR, TPE-S, Silicone | USP Class VI, ISO 10993-10 | Seals and gaskets for diagnostic equipment, soft-touch grips for handheld devices, vibration dampeners. |
| High-Temp Polymers | PAI, PPS, PEEK GF30 | UL94 V-0, FDA compliant | Sterilization trays, fluid handling |
ISO 13485 & ISO 9001 Certified Medical Manufacturing
TDB Tech’s ISO 13485:2016 and ISO 9001:2015 certifications are engineered into our medical component production. This dual-compliance framework ensures:
- Full traceability from raw material to finished part.
- Validated manufacturing with SPC monitoring.
- Audit-ready technical files.
- No recycled materials used in any production.
| KPI | Performance | Industry Average |
|---|---|---|
| Material Traceability | 100% | 78% |
| Document Accuracy | 99.98% | 95% |
| CAPA Closure Time | <72 hrs | 14 days |
| Medical Device PPM | <500 | 2,500 |
This certification governs our entire operation. For you, this means
We utilize designated clean workstations for assembling sensitive components and maintain precise mold temperature monitoring (±1°C).
We provide 100% dimensional reports for critical components and can implement automated testing protocols, such as leak testing for sealed diagnostic cartridges.
We apply this medical-grade quality mindset to every project, which means:
You receive a comprehensive First Article Inspection (FAI) report for approval before we begin full production.
Our closed-loop CAPA (Corrective and Preventive Action) system ensures that any potential nonconformity is addressed and resolved in under 72 hours—a fraction of the industry average.
Trusted by Industry Leaders in Medical Technology
- Diagnostic Equipment Makers
- Laboratory Automation Companies
- Medical Imaging System Developers
- Healthcare Robotics Innovators
- Wearable Health Tech Pioneers
- Life Science Instrument Providers
“Switching to First Mold for our robotic sample handler’s CNC-machined chassis was the best decision we made. In over 50,000 units delivered, we’ve had zero field failures related to their components. Their 100% on-time delivery has been critical in preventing any line-down situations for us.”
“Switching to First Mold for our robotic sample handler’s CNC-machined chassis was the best decision we made. In over 50,000 units delivered, we’ve had zero field failures related to their components. Their 100% on-time delivery has been critical in preventing any line-down situations for us.”
Frequently Asked Questions
You mention an ISO 13485 certification. Can you clarify its scope?
Absolutely. We hold ISO 13485:2016 certification specifically for the manufacturing of components for medical hearing aids. This demonstrates our capability to operate under the rigorous quality management demands of the medical industry. We apply this same medical-grade quality mindset, including robust traceability and process controls, to every component we produce.
My application is a diagnostic instrument housing. Do I need a cleanroom?
For most diagnostic, laboratory, and external medical equipment, a certified cleanroom is not required and adds unnecessary cost and complexity to your project. Our facility is a climate-controlled, highly clean, and organized environment perfect for these applications. We focus on delivering exceptional quality and precision where it matters most for your non-sterile device.
How do you guarantee the dimensional accuracy of your components?
We guarantee accuracy through a multi-stage verification process. It begins with a detailed First Article Inspection (FAI) report, which you approve before mass production. During production, we use Statistical Process Control (SPC) and regular in-process checks. Finally, we use advanced metrology equipment, including CMMs and VMMs, for final inspection. You receive a comprehensive quality report with every shipment.
How do you ensure material traceability from Mexico production?
Our Mexico facility uses a Lot-to-Melt tracing system compliant with ISO 13485:2016 Clause 7.5.9.2. Each component batch (e.g., *VALVE-2025MX-0876*) links to:
Raw material melt certificates
Process validation records
Sterilization compatibility data
What does your Design for Manufacturability (DFM) analysis include?
Our DFM analysis is a complimentary, collaborative step to optimize your design. We analyze factors like wall thickness, draft angles, material selection, and potential for tooling simplification. The goal is to proactively identify opportunities to reduce part cost, improve molding cycle times, and enhance the long-term reliability of your component, all before any steel is cut.
What are your typical lead times for a new project?
Lead times vary by complexity, but a typical project follows this timeline: After receiving your final design, a comprehensive quote based on expert review is provided within 24-48 hours. DFM analysis takes 2-3 days. For injection molding, first shots from new tooling are typically ready in 7-15 days. For CNC machining, lead times for initial parts can be as short as 5-7 days.
What types of design files do you accept?
We accept a wide range of 3D and 2D files. For the most efficient process, we prefer 3D CAD files in STEP (.stp), IGES (.igs), or Parasolid (.x_t) formats. We can also work with native files from SolidWorks, and we require 2D drawings (in PDF or DWG) to specify critical tolerances, threads, and surface finishes.
Can your inspection detect particulate contamination in clear components?
Yes. Our System detects ≥5μm particulates in transparent parts (e.g., IV connectors) with:
- Accuracy: 99.97% (vs. 92% manual inspection)
- Speed: 500 parts/minute
- Compliance: FDA 21 CFR Part 11 audit trail
How quickly can China/Mexico production shift for Class III device emergencies?
72-hour activation protocol:
- Hour 0-24: Process validation at MX facility (using China-qualified tools)
- Hour 24-48: First-article inspection (FAI per AS9102)
- Hour 48-72: Volume ramp-up (max. 200k parts/week)
What real-time monitoring is available for overseas implant production?
Clients access:
- Live Process Feeds: Machine sensors (e.g., temperature, pressure)
- Quality Gates: Dimensional checks via in-line CMMs
- Alerts: SMS/email for deviations (e.g., ±0.01mm tolerance breach)